Events

Recall of Device Recall LIFEPAK 20

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
    46351
  • Event Risk Class
    Class 2
  • Event Number
    Z-1050-2008
  • Event Initiated Date
    2008-01-08
  • Event Date Posted
    2008-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67227
  • 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
    External Automatic Defibrillator - Product Code MKJ
  • Reason
    Inoperable device - potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the printed circuit board assemblies (pcba).
  • Action
    The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units.

Device

Device Recall LIFEPAK 20
  • Model / Serial
    Serial Numbers (domestic units): 36133753, 36133760, 36139018, 36139023, 36139030, 36137448, 36138998, 36141356, 36141357, 36141358, 36141360, 36141361, 36141362, 36141363, 36141365, 36141366, 36141367, 36141370, 36141373, 36141378, 36141380, 36141381, 36141382, 36141383, 36141384, 36141393, 36141394, 36141395, 36141396, 36141399, 36141400, 36142717, 36142718, 36142730, 36142731, 36141386, 36141398, 36133739, 36133740, 36133742, 36133743, 36133744, 36133745, 36133746, 36133747, 36133748, 36133749, 36133750, 36133751, 36133752, 36133754, 36133755, 36133756, 36133757, 36133758, 36133759, 36137218, 36137219, 36137220, 36137222, 36137224, 36137225, 36137226, 36137227, 36137230, 36137231, 36137352, 36137353, 36137355, 36137356, 36137357, 36137359, 36137360, 36137361, 36137362, 36137363, 36137364, 36137365, 36137366, 36137367, 36137368, 36137369, 36139002, 36139010  Serial Numbers (international units): 36137354, 36137358, 36137370, 36137371, 36137372, 36138999, 36139000, 36139005, 36139006, 36139007, 36139009, 36139011, 36139012, 36139013, 36139014, 36139021, 36139024, 36139025, 36139031
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany.
  • Product Description
    Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052
  • 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