Jan

2005

Philips Medical Systems Class II

Company: Philips Medical Systems
Date of Enforcement Report: 1/12/05
Class: II

PRODUCT
Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05.

REASON
In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy.

CODE
Software versions A.02.00 and lower.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on December 13, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,520 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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