FDA-Device2020-05-27Class II
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.
Philips North America, LLC
Hazard
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Sold states
Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.
Affected count
8 units (2 US and 6 OUS)
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2064-2020Don't want to check this manually?
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