Events

Recall of Batteries for XL Defibrillator/Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    63116
  • Event Risk Class
    Class 2
  • Event Number
    Z-0011-2013
  • Event Initiated Date
    2012-09-11
  • Event Date Posted
    2012-10-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112615
  • 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
    Heartstart xl defibrillator/monitor (m4735a) used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.
  • Action
    The firm, Philips Healthcare, sent an "URGENT-MEDICAL DEVICE RECALL/Field Safety Notice" letter dated September 6, 2012 to its customers. The letter describes the product, problem and actions to be taken by the customer and also identifies what action Philips plans to take to remedy the issue. The customers were instructed to operate the XL and AC power instead of battery power alone; use a battery from a different date of manufacture (must not have the R-2011-12 date of manufacture code) if they need to operate the XL on battery power alone; and use an alternative source for treatment or therapy (i.e., backup defibrillator/monitor) if unable to operate with AC power alone or locate a battery with a different date of manufacture than that identified. Phillips will provide a replacement battery(s) to customers as soon as new production is available. If you need any further information or support concerning this issue, contact your local Philips representative or call Quality Specialists,Recalls at 978-687-1501 or email: debra.levasseur@philips.com.

Device

Batteries for XL Defibrillator/Monitor
  • Model / Serial
    HeartStart XL battery M3516A labeled with Made in Taiwan and an R-2011-12 Date of Manufacture
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of: AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KUWAIT LEBANON, MACAU, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VIET NAM.
  • Product Description
    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries || The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA