Reported Jun 3, 2020 · Terminated

Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A
  • and M3536M - Product Usageis for use for the termination of ventricular tachycardia and ventricular fibrillation
Lot codes and dates
  • Serial Numbers

    260 of 260 codes

    • US00100834
    • US00568320
    • US00101892
    • US00102393
    • US00206641
    • US00330166
    • US00207698
    • US00101198
    • US00602579
    • US00002011
    • US00101199
    • US00102000
    • US00102001
    • US00206119
    • US00206643
    • US00206812
    • US00206843
    • US00207050
    • US00210171
    • US00210937
    • US00210939
    • US00211096
    • US00211098
    • US00212132
    • US00212133
    • US00212134
    • US00213504
    • US00213507
    • US00317103
    • US00322662
    • US00327284
    • US00327290
    • US00327294
    • US00327796
    • US00327799
    • US00500001
    • US00534511
    • US00534512
    • US00534513
    • US00534514
    • US00535445
    • US00536360
    • US00536361
    • US00539849
    • US00539850
    • US00539851
    • US00539852
    • US00540841
    • US00545611
    • US00546914
    • US00546915
    • US00549033
    • US00549394
    • US00549396
    • US00549397
    • US00550766
    • US00550767
    • US00550768
    • US00550769
    • US00550770
Amount recalled
260 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 19, 2021 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.