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

Reason: eCareManager (eCM) Sentry Score software not approved for use

Code information: 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

Distribution pattern: Worldwide distribution - US Nationwide and the country of Australia.