Company: Philips North America LLC
Date of Enforcement Report: 2/9/2022
Class II
PRODUCT
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.
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
Model Number: 865325
Recall Number: Z-0549-2022
REASON
eCareManager (eCM) Sentry Score software not approved for use.
RECALLING FIRM/MANUFACTURER
Philips North America LLC on 1/3/2022. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
U.S. Nationwide and International