Events

Rappel de Device Recall Phiips Medical Systems

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Healthcare Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57846
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1609-2011
  • Date de mise en oeuvre de l'événement
    2011-02-07
  • Date de publication de l'événement
    2011-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97561
  • Notes / Alertes
    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
    Automated External Defibrillators (non-wearable) - Product Code MKJ
  • Cause
    Software: etco2 and ventilation rate values may be labeled incorrectly.
  • Action
    Philips Healthcare representatives issued an Urgent Medical Device letter on 2/7/11. Customers are asked to follow the Action to be taken by Customer/User section of the Urgent Medical Device Correction Notification. In this section, customers are given the following instructions: Philips software (SW) version F.01.03 (for M3535A and M3536A) and R.01.00 (for M3536A, English only) corrects this problem. If you have affected product a Philips Service Engineer will contact you to install software version F.01.03 or R.01.00. Until your software is updated your HeartStart MRx monitor/defibrillator can remain in service. If you are using the device in one of the use modes listed under problem description, make sure that operators are aware that even though the EtCO2 and ventilation rate values can display interchangeably (unexpectedly or randomly switch) under either the ventilation rate label or the EtCO2 label, the values themselves can be identified by their color (for example if the ventilation rate label is white, the ventilation value is displayed as white). Customers are to contact their local Philips representative at 1-800-722-9377, if they need further information or support regarding this issue.

Device

Device Recall Phiips Medical Systems
  • Modèle / numéro de série
    Software versions: F.01.00 or F.01.01
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide -- USA, Canada, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KENYA, LATVIA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, REUNION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Description du dispositif
    Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. || Used for the termination of ventricular tachycardia and ventricular fibrillation.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA