Recalls / —

—#38809

Product

Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A

FDA product code

MKJ — Automated External Defibrillators (Non-Wearable)

Device class

Class 3

Medical specialty

Cardiovascular

510(k) numbers

K031187

Affected lot / code info

Software Versions A.03.00 or lower and B.04.00 and lower

Why it was recalled

The device may disarm and not deliver shock when performing a Synchronized Cardioversion

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.

Recalling firm

Firm

Philips Medical Systems

Address

3000 Minuteman Road, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern

Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapore Spain, Sweden, Switzerland, Tawian, Thailand, Tunisia, UK, United Arab Emirates, Yemen

Timeline

Recall initiated

2005-04-29

Posted by FDA

2005-05-17

Terminated

2010-09-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #38809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.