Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The neonatal flow sensor cable may be missing the connector housing exposing the wires in the cable. if the exposed wires break, primary ventilation parameters could be lost (flow and tidal volume). this issue may cause indirect but reversible changes in the patient’s condition as these parameters, among other information, are used in choosing appropriate ventilator settings for the patient.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
When an external display is connected to the carescape monitor b650 using a usb extender cable with an active usb hub, the system may experience a sound loss including alarm sounds from the patient monitor.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Ge healthcare has recently become aware of an issue related to the operation of the safety latch within the column that supports the horizontal arm. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. a fall of the arm assembly could result in bodily harm to a person. there have been no incidents or injuries reported as a result of this internally found issue.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Cause
Ge healthcare has become aware of a potential set of circumstances that could cause x-ray continuation during
an unexpected table stop on certain brightspeed systems. if this event were to occur on your system, patient
safety may be impacted.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Specific workflows of your centricity universal viewer (uv) workstation can cause a loss of synchronization in the patient context between uv and either senoiris or idi mammo workstation.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Centricity pacs-iw versions 3.6.0 through 3.7.3.9 sp1, sp2 and sp3, 3.7.3 spa10.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Outer enclosure material may not meet intended flammability and fluid ingress ratings.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Screws from the “heater head” of the lullaby warmer may come loose over time and could fall onto the bed. this situation can be clinically hazardous because potential thermal injury to a patient could result.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Cause
1. inline post-processed image
locations are not
correctly annotated
under some conditions.
2. reference images
displayed in functool
fibertrak do not match
with the orientation
annotations under some
conditions.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Part of the cable assembly may overheat when the device is used. rarely this could result in minor burn injury in case of prolonged direct skin contact with the overheating part.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
(1) carescape monitor b850 udom failure.
it is possible that the carescape monitor b850 may enter into a constant boot loop causing monitor to reboot continuously
(2) carescape monitor b850 unstable usb communication
(3) carescape monitor b850 reboots due to an x server freeze.
(find attached file for more details).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
At certain sites, the mru may not be connected to the magnet. if the mru is disconnected, the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase-contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence, the magnitude weighting mask is a user configurable option (control
variable or cv). in the 2d cine phase-contrast sequence (non-fast mode), magnitude weighting mask is always on, and thus would always result in this issue.
the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
The predicted head sar value from the modeling, when using ge healthcare 3.0t mr scanners with the whole body rf transmit coil and receive-only surface coils for head and/or neck imaging, suggests that actual sar delivered to the head could potentially exceed the 3.2 w/kg sar limit defined in iec60601-2-33. this issue does not affect mr scans performed outside the head and neck areas.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
1-within the sureloc application, under sureloc preferences, there are two grid options: a generic grid or the ge 8-channel curved grid. a generic grid is a flat grid of 2 centimeter holes. there is no limitation on the number of
blocks.
2-this recall has been initiated due to a necessary modification to the cadstream difference threshold when cadstream is used in conjunction with the ge phased array uniformity enhancement (pure) for dynamic mri imaging and a lack of notification when cadstream detects the pure filter has been used.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
After boot-up or system start up, cscs v2.0.2 units may display unexpected no comm notifications in the patient multi-viewer or single viewer window when the cscs is connected to both the mission critical (mc) and the information exchange (ix) networks.
all-in-one gtin 00840682109666; desktop gtin 00840682109604.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
(1) spo2 saturation limit alarm does not always activate when nellcor spo2 is used in pdm and saturation seconds is not switched on.
(2) when the carescape monitor b650 is connected to the unity id and information from a 3-lead ecg cable is transferred through dri (s/5) network, the monitor may reboot
(find attached file for more reasons).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Ge healthcare has recently become aware of a bucky device falling from the wall stand as a result of the breakage of its supporting cables.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Canopy seals not cleaned properly on systems with original seal design, potential contamination.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
There have been reported incidents of a patient step detaching from the table. a fall from a patient step detaching while in use could result in an injury to a patient or operator.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Imtmedical has identified that potential friction of cables and tubing internal to the evair compressor may result in an inability for the compressor to output compressed air.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Ge healthcare has become aware of an issue associated with the base casting for the articulated arm of the vmx and vmx plus mobile x-ray systems that may impact operator or patient safety.
the casting which retains the articulated arm to the base of the vmx may develop fatigue cracks through long term use of the product. if the casting develops cracks of significant size, the articulated arm may no longer be properly secured to the base of the vmx. the loss of retention may permit the articulated arm, x-ray tube, and collimator to fall in an uncontrolled manner. the fall of this object may create a hazard to operators and patients during transport or use of the equipment.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notes supplémentaires dans les données
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Cause
Ge healthcare found that in rare cases the infinia lateral gear does not meet engineering design specifications. this may cause accelerated fatigue of the lateral axis motion subsystem which may lead to a detector sliding during lateral movement, which could potentially introduce a patient or operator to direct impact associated with permanent impairment.