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Philips North America Llc recalls eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareMan
Recalled February 9, 2022 · FDA recall Z-0549-2022 · Philips North America
Hazard
eCareManager (eCM) Sentry Score software not approved for use · FDA Class II
Units
36 units
Sold at
Worldwide distribution - US Nationwide and the country of Australia.
Description
eCareManager (eCM) Sentry Score software not approved for use
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
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →