Events

Recall of Device Recall Philips Healthcare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems, 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
    67052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0593-2014
  • Event Initiated Date
    2013-06-07
  • Event Date Posted
    2013-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124617
  • 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
    Error in the printing of the therapy energy setting labels on philips heartstart m3536a mrx monitor/defibrillators. the first energy setting is labeled 10 when it should be labeled1-10.
  • Action
    Philips sent a Customer Information Letter dated June 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. During an EI of the firm, the firm had not reported the correction to FDA. The Customer Information letter informs the customers what the behavior is and under what circumstances. The correction consisted of a replacement label that was provided free of charge to all units affected by this issue. Philips Healthcare representatives have been contact customers with affected devices to arrange for installation of the replacement label. To correct this issue, Philips will replace the label free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the replacement label. This issue does not affect current product shipments. I f you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. Philips apologizes for any inconvenience caused by this problem.

Device

Device Recall Philips Healthcare
  • Model / Serial
    Serial numbers: US00558442 - US00558461 US00561519 US00558531 - US00558532 US00561578 US00558615 US00562454 US00558758 - US00558759 US00562504 - US00562527 US00560165 - US00560166 US00562640 - US00562641 US00560738 - US00560739 US00562832 US00560740 - US00560745 US00563125 US00560872 US00563231 - US00563243 US00560909 US00564032 US00561068 US00564177 US00561209 US00564409 US00561447 - US00561452 US00564793
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.
  • Product Description
    Philips HeartStart MRx Monitor/Defibrillator || Models: M3536A Options A20 - A27, HeartStart MRx ALS || Monitor (Grey) || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA