U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Software defect causing intermittently slow response of host.
Action
On 3/24/2016 the firm mailed Customer Information letters to their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Glucose Oxidase, Glucose - Product Code CGA
Cause
Use of glucose blood strips may provide false high results.
Action
Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Reagent, Immunoassay, Igg - Product Code KTO
Cause
Kit does not stain tissues properly.
Action
Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Cause
Potential for false negative patient results with software version 3.0.
Action
An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Enzymatic Methods, Galactose - Product Code JIA
Cause
The device is not stable throughout its labeled expiration date.
Action
The firm contacted their customers by telephone and facsimile on 5/30/2003.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Enzymatic Methods, Galactose - Product Code JIA
Cause
The device is not stable throughout its labeled expiration date.
Action
The firm contacted their customers by telephone and facsimile on 5/30/2003.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Igg, Antigen, Antiserum, Control - Product Code DEW
Cause
Low level igm serum sample results may be suppressed and an error code generated when using affected lots. error codes are seen as e60 or e66.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
Cause
The aso (mpe) assayed in buffer cannot be programmed or calibrated using array calculator 5.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Heart-Valve, Allograft - Product Code MIE
Cause
Records noted that the infant donor's mother had tested positive for hepatitis b.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Software defect causing intermittently slow response of host.
Action
On 3/24/2016 the firm mailed Customer Information letters to their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Software defect causing intermittently slow response of host.
Action
On 3/24/2016 the firm mailed Customer Information letters to their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, Blood Culturing - Product Code MDB
Cause
A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
Action
Consignees were notified by letter on May 27, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, Blood Culturing - Product Code MDB
Cause
A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
Action
Consignees were notified by letter on May 27, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, x-ray, tomography, computed - Product Code JAK
Cause
Software defect causing intermittently slow response of host.
Action
On 3/24/2016 the firm mailed Customer Information letters to their customers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, Blood Culturing - Product Code MDB
Cause
A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
Action
Consignees were notified by letter on May 27, 2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Cassette, Radiographic Film - Product Code IXA
Cause
Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
Action
Consignees were notified by letter on/about 07/29/2005.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
System, nuclear magnetic resonance imaging - Product Code LNH
Cause
Potential risk for helium gas inside the mr examination room during a magnet quench.
Action
On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm.
**Action to be Taken by Customer**:
During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use:
Release of helium gas in the examination room"
If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation.
If helium enters the examination room:
" Immediately remove all persons from the examination room.
" Do not switch off air circulation and ventilation in the examination room.
" Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level.
"Emergency procedures"
The User is required to establish emergency procedures for the following situations:
" A medical emergency
" A fire
" An emergency that requires immediate removal of the magnetic field
" The release of helium gas into the examination room
Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement.
(Instructions for Use R5.3)
Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff