Philips North America, LLC recalls HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/De…

Recall date

April 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2064-2020

FDA classification

Class II

Brand / firm

Philips North America, LLC

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of OK, NY and the countries of Libya, Netherlands, Canada, South Africa, United Kingdom.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.