—#84415

Product

HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE 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 basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K031187
Affected lot / code info: Serial numbers within the following range. US00533518 through US00535118.

Why it was recalled

incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power

Root cause (FDA determination)

Process change control

Action the firm took

Philips Healthcare issued a Urgent Voluntary Medical Device Correction Notification on August 21, 2009 advising users of the problem and Customers are asked to follow the "Action to be taken by customer/user" section of the Urgent Voluntary Medical Device Correction Notification. In this section, customers are given the instructions to correct their devices. For further information or support concerning this issue, please contact Philips representative at 1-800-722-9377.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Nationwide Canada Australia, Austria, Beharin, BRUNEI DARUSSALAM,Chian,. Finland, France, Germany,Hong Kong, India, Indonesia, Ireland, Israel,Italy, Japan, Libya, Lithuania. Mexico, Nambia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, UAE, UK

Timeline

Recall initiated: 2009-08-21
Posted by FDA: 2009-11-09
Terminated: 2017-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84415. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.