medical Class II Updated 2022-02-09

Philips North America Llc recalls eCareManager version 4.2.1, eCareManager version 4.3.2, eCar

Recalled Product

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 management and care of in-hospital patients. Model Number: 865325

Hazard / Issue

eCareManager (eCM) Sentry Score software not approved for use

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Version/ UDI 4.2.1 (01)00884838087453(10)4.2.1 4.3.2* (01)00884838099807(10)4.3.2(11)20200610 4.3.3 (01)00884838099807(10)4.3.3(11)20210811 4.5.1 (01)00884838102910(10)4.5.1(11)20210321 4.5.2 (01)00884838102910(10)4.5.2(11)20210802 4.6.0 (01)00884838106963(10)4.6.0(11)20211014
View official government recall

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