Reported Jul 17, 2019 · Terminated
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2,…
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 devices
- in use with the M3539A AC Power Module
M3535AM3536AM3536MM3536MCM3536M2M3536M3M3536M4M3536M5M3536M6M3536M7M3536M8M3536M9
- Lot codes and dates
- Serial numbers
2,716 of 2,716 codes
US00321116US00205647US00205648US00554104US00554105US00554106US00559530US00559531US00559532US00559533US00559534US00559535US00559536US00559537US00559538US00559539US00321076US00321222US00322701US00544495US00320900US00580288US00580298US00580334US00580335US00580336US00580337US00580338US00582916US00582917US00582918US00582919US00582920US00582921US00582922US00582923US00582924US00582925US00582926US00582927US00582928US00582929US00582930US00582931US00582932US00582933US00582934US00582935US00582936US00582937US00582938US00582939US00582940US00582941US00582942US00582943US00582944US00582945US00582946US00582947
- Serial numbers
- Amount recalled
- 97,794 Units
Where it was sold
- Nationwide
Why it was recalled
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
This product could cause temporary or reversible health problems — stop using it.
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