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Philips North America, LLC recalls HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/De
Recalled May 27, 2020 · FDA recall Z-2064-2020 · Philips North America
Hazard
Damaged ESD bags used for storing components in Processor PCA Replacement Kits · FDA Class II
Units
8 units (2 US and 6 OUS)
Sold at
Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.
Description
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
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.
Manufacturer(s)
Philips North America, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →