Events

Recall of Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physio Control, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54005
  • Event Risk Class
    Class 2
  • Event Number
    Z-0811-2010
  • Event Initiated Date
    2009-03-31
  • Event Date Posted
    2010-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87123
  • Notes / Alerts
    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.
  • Extra notes in the data
    automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    Affected devices contain a biphasic pcba that may have a solder defect on the h bridge component that could prevent the device from providing a defibrillation shock. there could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. delay or prevention of defibrillation therapy may contribute to the death of a viable patient.
  • Action
    Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.

Device

Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR
  • Model / Serial
    Part Number: LP12, VLP12-02-(various dash numbers).  Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334, 10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980, 11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139, 11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222, 11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135, 12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932, 12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439, 12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842, 13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186, 14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840, 37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327, 37126328, 37126329, 37126330, 37126331, 37126332, 37126333, 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37628552, 37628553, 37628554, 37628555, 37628556, 37628557, 37628558, 37628559, 37628560, 37628561, 37628562, 37628563, 37628564, 37628565, 37628566, 37628567, 37628568, 37628569, 37628570, 37628571, 37628572, 37628573, 37628574, 37628575, 37628576, 37628577, 37628578, 37628579, 37628580, 37628581, 37628582, 37628583, 37628584, 37628585, 37628586, 37628587, 37628588, 37628589, 37628590, 37628591, 37628592, 37628593, 37628594, 37628595, 37628596, 37628597, 37628598, 37628599, 37628600, 37628601, 37628602, 37628603, 37628604, 37628605, 37628606, 37628607, 37628608, 37628609, 37628610, 37628611, 37628612, 37628613, 37632499, 37632500, 37632501, 37632502, 37632503, 37632504, 37632918, 37632922, 37632941, 37632945, 37632946, 37632947, 37632948, 37632951, 37632952, 37632953, 37632955, 37632956, 37632958, 37632959, 37632960, 37632961, 37632963, 37632964, 37632967, 37633634, 37633636, 37636570, 37636571, 37636572, 37636573, 37636574, 37636575, 37636576, 37636577, 37636578, 37636579, 37636659, 37652880, 37652883, 37652883, 37660898, 37660902, and 37661630.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.
  • Product Description
    Biphasic LIFEPAK 12 defibrillator / monitor.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Manufacturer Address
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA