Reported Jan 21, 2015 · Terminated
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4,…
Philips Medical Systems, 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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- HeartStart MRx Monitor/Defibrillator; Model
- Numbers
M3535AM3536AM3536JM3536MM3536MCM3536M2M3536M4M3536M5
- M3536M6 Product UsageThe HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
- Lot codes and dates
9 of 9 products
Products covered by this recall Model / number Product as published M3535AUS00100100 to US00576623 M3536AUS00100902 to US00576650 M3536JUS00209838 to US00332675 M3536MUS00500002 to US00553553 M3536MCUS00500001 to US00500087 M3536M2US00554176 to US00554178 M3536M4US00500003 to US00574869 M3536M5US00500001 to US00562935 M3536M6US00554358 to US00576619 - Amount recalled
- 74,499 devices
Where it was sold
- Nationwide
Why it was recalled
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
This product could cause temporary or reversible health problems — stop using it.
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