Philips North America Llc: 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 sof

Is my product affected?

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 managem

• UPC 00884838087453
• UPC 00884838099807
• UPC 00884838102910
• UPC 00884838106963

Check against the official notice below — it lists the full affected range.

What happened

Philips North America LLC is recalling eCareManager software versions 4.2.1, 4.3.2, 4.3.3, 4.5.1, 4.5.2, and 4.6.0 because the Sentry Score software component within these versions was not approved for use. A total of 36 units were distributed worldwide, including across the United States and Australia.

The source document does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

eCareManager (eCM) Sentry Score software not approved for use

Details from the source

Reason for recall: eCareManager (eCM) Sentry Score software not approved for use Distribution: Worldwide distribution - US Nationwide and the country of Australia. Quantity: 36 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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