Company: Philips Medical Systems
Date of Enforcement Report: 9/24/03
Class: II
PRODUCT
HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.M
CODE
Units with software versions A.02.00 or greater.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing.
REASON
Instructions for use include additional information on configuration for selecting Power on Lead.
VOLUME OF PRODUCT IN COMMERCE
16,736 units.
DISTRIBUTION
Nationwide and Internationally.
