Reported May 27, 2020 · Terminated
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx…
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?
- HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx
- Monitorl/Defibrillator - Product Usageis intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation
- Lot codes and dates
- Serial Numbers
CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2CO1-1639100N43 C01-1639100ND0 C01-16391D0N6NC01-16391D0N4N C01-1&39IDON1J
- Serial Numbers
- Amount recalled
- 8 units (2 US and 6 OUS)
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
Why it was recalled
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
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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