FDAFebruary 20, 2023device

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

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

The hazard

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

What to do

FDA enforcement status: Ongoing

Brands named

philips medical systems nederland b vphilipsphilips medical

UPCs

00884838088566722027722028722067722068459801530271

Recall history

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

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