medical Class II Updated 2020-05-27

Philips North America, LLC recalls HeartStart MRx Processor Board PCA Replacement Kits 4535634

Recalled Product

HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is 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.


Hazard / Issue

Damaged ESD bags used for storing components in Processor PCA Replacement Kits

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J
View official government recall

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