Reported Apr 5, 2017 · Terminated

HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2,…

Philips North America, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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?

  • HeartStart MRx Monitor/Defibrillator
  • Model numbers
    • M3535A (M3535ATZ) M3536A (M3536ATZ)
    • M3536M
    • M3536MC
    • M3536M2
    • M3536M4
    • M3536M5
    • M3536M6
    • M3536M7
    • M3536M8
    • M3536M9
Lot codes and dates
  • Model# Serial Numbers M3535A US00100100 to US00602546 M3535ATZ US00100100 to US00602546 M3536A US00100902 to US00602540 (M3536ATZ) US00100902 to US00602540 M3536M US00500002 to US00553553 M3536MC US00500001 to US00500087 M3536M2 US00554176 to US00554178 M3536M3 US00571854 to US00588995 M3536M4 US00500003 to US00590982 M3536M5 US00500001 to US00587771 M3536M6 US00554358 to US00600582 M3536M7 US00581047 to US00601962 M3536M8 US00590958 to US0059095 M3536M9 US00581048 to US00581049
Amount recalled
97,794 total ( 47,362 US and 50,429 OUS)

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Stop using this product now

HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a single battery as the sole source of power may fail to deliver therapy or monitoring

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 17, 2020 · Data as of Sep 19, 5:30 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.