Z-0549-2022 Class II Terminated
FDA device recall Z-0549-2022 was initiated by Philips North America Llc on Jan 3, 2022 and is designated Class II. Reason for recall: eCareManager (eCM) Sentry Score software not approved for use The recall status is terminated (terminated Apr 11, 2024). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 9, 2022
- Initiation Date
- Jan 3, 2022
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0549-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026