Home / Recalls / Philips North America, LLC / Z-2064-2020

Z-2064-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
May 27, 2020
Initiation Date
April 10, 2020
Termination Date
February 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 units (2 US and 6 OUS)

Product Description

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.

Reason for Recall

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

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.

Code Information

Serial Numbers: CO1-1643IDOTDB CO1-1639100N3T C01-16391D0NB2, CO1-1639100N43 C01-1639100ND0 C01-16391D0N6N, C01-16391D0N4N C01-1&39IDON1J

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