Company: Philips Medical Systems
Date of Enforcement Report: 5/25/05
Class: II
PRODUCT
Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05.
REASON
The device may disarm and not deliver shock when performing a Synchronized Cardioversion.
CODE
Software Versions A.03.00 or lower and B.04.00 and lower.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on May 2, 2005. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,125 units.
DISTRIBUTION
Nationwide and Internationally.
