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FDASeptember 10, 2019device

Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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