Sep

2003

Philips Medical Systems Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Philips Medical Systems Class II

Amy Sellers

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