Apr

2011

Philips HeartStart MRx Defibrillator Monitor Cl ll

Company: Philips Healthcare Inc.
Date of Enforcement Report 4/6/2011
Class ll:

PRODUCT
Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. Used for the termination of ventricular tachycardia and ventricular fibrillation. Recall # Z-1609-2011

REASON
Software: EtCO2 and Ventilation Rate values may be labeled incorrectly.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter on February 7, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2382 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 HeartStart MRx Defibrillator Monitor Cl ll

Amy Sellers

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