Reported Nov 11, 2015 · Terminated
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and 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/Defibrillators ModelsM3535A and M3536A
- Lot codes and dates
- Serial Numbersthrough
US00101159US00322848US00326834US00328432US00328439US00328442US00328443US00328446US00328450US00328461US00328464US00328465US00328468US00328473US00328478US00330393US00533518US00533521
US00535118US00539526US00540124US00543102US00543104US00543138US00543158US00543161US00543166US00543167US00543187US00543204US00543223US00543239US00546804
- Serial Numbers
- Amount recalled
- 1553 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
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
This product could cause temporary or reversible health problems — stop using it.
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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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