eCareManager version 4 — Class II medical device recall Z-0549-2022
Terminated recall by Philips North America Llc, reported 2022-02-09, distributed nationwide. eCareManager (eCM) Sentry Score software not approved for use
| Recall number | Z-0549-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2022-01-03 |
| Classified | 2022-02-01 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2024-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 36 units |
| Reason classes | software, unapproved product |
| UPC / GTIN / UDI-DI | 00884838087453, 00884838099807, 00884838102910, 00884838106963 |
| Model numbers | 865325 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0549-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.