FDAJanuary 3, 2022device

eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the mana...

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

The hazard

eCareManager (eCM) Sentry Score software not approved for use

What to do

FDA enforcement status: Terminated

Brands named

philips north americaphilipsphilips north

UPCs

00884838087453008848380998070088483810291000884838106963

Recall history

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

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