FDA recall Z-0549-2022

Philips North America Llc · Class II · device

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

Reason for recall

eCareManager (eCM) Sentry Score software not approved for use

Distribution

Worldwide distribution - US Nationwide and the country of Australia.

Key facts

Status: Terminated
Initiation date: 2022-01-03
Report date: 2022-02-09
Termination date: 2024-04-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2022