Recall – Unapproved software released

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.