Device 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.
Z-2064-2020
Product summary
- Event
- Event 85462
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 units (2 US and 6 OUS)
- Official record key
device-enforcement:Z-2064-2020
Official wording
Reason: Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Code information: Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.
Derived failure modes
-
Unknown
Damaged ESD bags used for storing components in Processor PCA Replacement Kits