Events

Rappel de Device Recall LIFEPAK 15 Monitor/Defibrillator

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 Physio Control, 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
    54894
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1410-2010
  • Date de mise en oeuvre de l'événement
    2010-03-04
  • Date de publication de l'événement
    2010-04-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89398
  • 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
    Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off.
  • Action
    Physio-Control Inc. issued an "Urgent Medical Device Correction" notification dated March 2010 to domestic consignees. Foreign consignees were notified by overseas representatives. Consignees were advised to keep the affected device in service and to test the units in accordance with operating instructions. They were further advised that a local service representative will call and schedule a service visit within 60 days. Consignees were asked to forward the notification to all of their sites and to notify the recalling firm if they no longer own the device. For further information, contact Physio-Control Inc. Technical Support at 1-800-442-1142, Option 5, 6:00 am to 4:00 pm (Pacific), Monday-Friday.

Device

Device Recall LIFEPAK 15 Monitor/Defibrillator
  • Modèle / numéro de série
    Product part numbers: V15-2-000xxxxxx.  Serial Numbers: various, non-contiguous as follows:  Device Serial Numbers: 37799911, 37799913, 37799914, 37799915, 37800767, 37800768, 37800769, 37800771, 37803641, 37803642, 37803643, 37803644, 37803645, 37803646, 37803647, 37803648, 37803650, 37803651, 37804604, 37804605, 37804606, 37804607, 37804615, 37805136, 37805137, 37805138, 37805139, 37805140, 37805141, 37805142, 37805143, 37805144, 37805145, 37805146, 37805147, 37805148, 37805149, 37805150, 37805151, 37805152, 37805153, 37805154, 37805155, 37805156, 37805157, 37805158, 37805159, 37805160, 37805161, 37805162, 37805163, 37805164, 37805165, 37805166, 37805167, 37805168, 37805169, 37805170, 37805171, 37805172, 37805173, 37805174, 37805182, 37805183, 37805184, 37805185, 37805186, 37805187, 37805188, 37805189, 37805190, 37805191, 37805192, 37805193, 37805194, 37805195, 37805196, 37805197, 37805198, 37805199, 37805201, 37805202, 37808586, 37808587, 37808588, 37808589, 37808590, 37808591, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong.
  • Description du dispositif
    Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA. || The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient protocols.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Adresse du fabricant
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA