Medical device recalls Moderate risk

Philips Electronics North America Corp. recalls Philips HeartStart FRx AED.

Recall date
March 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1913-2018
FDA classification
Class II
Brand / firm
Philips Electronics North America Corp.
Sold / distributed
Distribution was nationwide and to Puerto Rico. There was also government/military distribution. Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Brunei Darussalam,…

Why it was recalled

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.

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

What was recalled

Philips HeartStart FRx AED.

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