Reported Mar 19, 2014 · Terminated
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A,…
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?
- Philips HeartStart
- MRx Monitor/Defibrillator Model numbers
M3535AM3536AM3536MM3536M4M3536M6861288861289861464861483and 861491
- Lot codes and dates
- Serial numbers within the rangeUS00100204 to US00570921
- Amount recalled
- 3541 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
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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