Home / Recalls / Philips North America Llc / Z-0549-2022

Z-0549-2022 Class II Terminated

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
February 9, 2022
Initiation Date
January 3, 2022
Termination Date
April 11, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 units

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

Reason for Recall

eCareManager (eCM) Sentry Score software not approved for use

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Australia.

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

Other recalls by Philips North America Llc

  • Z-1952-2026 Class II — Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Num (April 14, 2026)
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  • Z-1964-2026 Class II — Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. (April 14, 2026)
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  • Z-1953-2026 Class II — Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7812 (April 14, 2026)