16
Apr
2014

Cl II Philips HeartStart XL+

0

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/16/2014
Class lI:

PRODUCT

Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
Recall Number Z-1438-2014

REASON
Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy..

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc.,Andover, MA on 4/2/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9872 units

DISTRIBUTION
Nationwide and Internationally

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About the author

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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