Events

Recall of Device Recall LIFEPAK 15 Monitor/Defibrillator

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
    54894
  • Event Risk Class
    Class 1
  • Event Number
    Z-1410-2010
  • Event Initiated Date
    2010-03-04
  • Event Date Posted
    2010-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89398
  • 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
    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
  • Model / Serial
    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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37870212, 37870213, 37870214, 37870215, 37870216, 37870217, 37870218, 37870219, 37870220, 37870221, 37870222, 37870223, 37870224, 37870225, 37870226, 37870228, 37870229, 37870236, 37870245, 37870247, 37870249, 37870250, 37870252, 37870254, 37870255, 37870258, 37870259, 37870260, 37900478, 37900488, 37900602, 37900603, 37900604, 37900608, 37900610, 37900612, 37900615, 37900616, 37900617, 37900623, 37900624, 37900625, 37900626, 37900628, 37900629, 37900630, 37900631, 37900632, 37900633, 37923078, 37923087, 37923100, 37923112, 37923125, 37923155, 37923156, 37923162, 37923201, 37923203, 37923204, 37923205, 37923206, 37923207, 37923208, 37923210, 37923211, 37923213, 37923214, 37924152, 37924153, 37924154, 37924155, 37924156, 37924160, 37924163, 37924164, 37924165, 37928454, 37928455, 37928456, 37928457, 37928458, 37928459, 37928460, 37928461, 37928462, 37928463, 37928790, 37928791, 37928792, 37928793, 37928794, 37928958, 37928960, 37928961, 37928964, 37928967, 37928968, 37930940, 37930942, 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38428179, 38428180, 38428181, 38428182, 38428183, 38428184, 38428185, 38428188, 38428189, 38428190, 38428191, 38428192, 38428193, 38428194, 38428195, 38428196, 38432094, 38432094, 38432100, 38432100, 38432101, 38432102, 38432103, 38432104, 38432105, 38432105, 38441911, 38441912, 38441913, 38441914, 38441915, 38441916, 38441917, 38441918, 38441919, 38441920, 38441921, 38441922, 38441922, 38441923, 38441925, 38441926, 38441927, 38441928, 38441929, 38441930, 38441931, 38441932, 38441933, 38441934, 38441935, 38441936, 38445572, 38445573, 38445574, 38445579, 38445580, 38445581, 38445582, 38445583, 38445584, 38445585, 38445590, 38445591, 38445593, 38445594, 38445595, 38445597, 38445599, 38445601, 38445604, 38445607, 38445611, 38445615, 38445619, 38445624, 38445626, 38445627, 38445630, 38445638, 38445640, 38445641, 38445646, 38445649, 38445650, 38445651, 38445652, 38448508, 38448509, 38448510, 38448511, 38448512, 38448513, 38448514, 38448515, 38448516, 38448517, 38448518, 38448520, 38448521, 38448522.38449344, 38449345, 38449346, 38449347, 38449348, 38449352, 38449357, 38449358, 38449359, 38449360, 38449362, 38449363, 38449364, 38449365, 38449367, 38449369, 38449370, 38449371, 38449374, 38449377, 38449378, 38449379, 38449381, 38449382, 38449384, 38449385, 38449387, 38449388, 38449390, 38449391, 38449392, 38449394, 38449400, 38449410, 38458601, 38458602, 38458603, 38458604, 38458605, 38458606, 38458608, 38458609, 38458610, 38458667, 38458668, 38458669, 38458671, 38458672, 38458673, 38458675, 38458676, 38458677, 38458678, 38458679, 38458680, 38458681, 38458683, 38458684, 38458685, 38458686, 38458687, 38458688, 38458690, 38458691, 38458695, 38458696, 38458697, 38458698, 38458700, 38458702, 38462717, 38472556, 38472557, 38472559, 38472560, 38472561, 38472562, and 38472569.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong.
  • Product Description
    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.
  • Manufacturer Address
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA