UnratedMedical device recall · FDA · Published January 3, 2022
Philips eCareManager Software Versions 4.2.1-4.6.0 Recalled: Unapproved Medical Software
Philips recalls specific versions of eCareManager software for in-hospital patient care. The unapproved software may not be safe for medical use. Affected units include model 865325 with listed software versions.
“Philips eCareManager Software Versions 4.2.1-4.6.0 Recalled: Unapproved Medical Software.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61321-philips-ecaremanager-software-versions-4-2-1-4-6-0. Based on FDA recall #Z-0549-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0549-2022%22&limit=1).
Philips North America Llc recalled eCareManager software versions 4.2.1, 4.3.2, 4.3.3, and 4.5.1 because the Sentry Score feature was not approved for use, according to the FDA. The agency announced the recall on January 3, 2022.
How to tell if you have it
eCareManager version 4.2.1
eCareManager version 4.3.2
eCareManager version 4.3.3
eCareManager version 4.5.1
Model Number: 865325
UPC 00884838087453
UPC 00884838099807
UPC 00884838102910
UPC 00884838106963
The hazard
The eCareManager Sentry Score software was not approved for use. The product is a software tool intended for trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients.
Context
GovInfoNow's records show Philips North America Llc has 129 other recalls on record since July 12, 2017. Other recent recalls include a SmartPath to dStream recall for software issues terminating examinations (August 21, 2026), a Spectral CT 7500 Scanner recall for potential extra radiation exposure (August 18, 2026), and an IQon Spectral CT Software recall for unintended radiation risk (August 7, 2026). Similar recent recalls of similar products include a Philips Patient Information Center iX Software Freeze recall (July 31, 2026) and a Siemens CT Software Applications recall for unapproved medical software (December 19, 2025).
How to tell if you have this one
Check if your hospital's eCareManager software shows version numbers 4.2.1, 4.3.2, 4.3.3, 4.5.1, 4.5.2, or 4.6.0 with model number 865325. The software versions are listed in the device's documentation or system settings.
Brand
Philips
Product
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version number in the device's documentation or system settings to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0549-2022 (January 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0549-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.