Philips North America Llc: Medical Device Recall in 2022 - (Recall #: Z-0549-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 3, 2022

Date Posted: February 9, 2022

Recall Number: Z-0549-2022

Event ID: 89489

Reason for Recall:

eCareManager (eCM) Sentry Score software not approved for use

Status: Terminated

Product Quantity: 36 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated