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
    76162
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-2017
  • Event Initiated Date
    2017-01-16
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152423
  • 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
    Cardiac Defibrillator/Monitor - Product Code MKJ
  • Reason
    The end-tidal co2 (etco2) reading can intermittently show a value of xxx after start-up or during device operation.
  • Action
    Physio Control sent the Urgent Medical Device Correction LIFEPAK 15 Monitor/ Defibrillator and LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 (EtCO2) option letter, dated January 2017, and confirmation sheets to consignees on January 16, 2017. Physio-Control is contacting customers with affected devices to schedule the correction of their device(s), which will include replacing the EtCO2 module. Required Customer Actions: 1. Please forward this information to all affected sites, trainers and users that may have affected LIFEPAK 12 or LIFEPAK 15 device(s). 2. Consignees should follow the instructions on the Confirmation Sheet for each serial number listed in their possession. Promptly return the completed Confirmation Sheet to Physio-Control. 3. If consignees experience the XXX after power-up or during device operation, please contact Physio-Control to arrange for servicing of their device. Consignees should return completed confirmation sheet: -By fax to: 1-866-448-9567 -By email to: rsrecall@physio-control.com -Or by mail to: Physio-Control, Inc. P.O. Box 97006, Dept. 15N Redmond, WA, 98073-9706 Consignees with questions can call the firm at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday.

Device

Device Recall LIFEPAK 12 Defibrillator/Monitor
  • Model / Serial
    LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544.  SERIAL NUMBERS OF DEVICES:  32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHILE, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, FRENCH GUIANA, GERMANY, GREECE, HUNGARY, ICELAND, IRELAND, ITALY, LITHUANIA, LUXEMBOURG, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SENEGAL, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TAHITI, UNITED ARAB EMIRATES, AND UNITED KINGDOM.
  • Product Description
    LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. || The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). || The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
  • 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