Reported May 8, 2013 · Terminated

HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5,…

Philips Healthcare Inc.

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 Healthcare Inc. · 3000 Minuteman Road · Andover, MA · 01810

Is this the product you have?

  • HeartStart MRx Monitor/Defribillator
  • Product CodesM3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation
Lot codes and dates
  • Serial numbers ranging from
  • US00100100 to US00565942 Product Codes
    • M3536A
    • M3536J
    • M3536M
    • M3536MC
    • M3536M2
    • M3536M4
    • M3536M5
    • M3536M6
Amount recalled
64972

Where it was sold

  • Nationwide

Why it was recalled

Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 10, 2017 · Data as of Sep 19, 5:28 PM UTC

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