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.
eCareManager (eCM) Sentry Score software not approved for use
Philips is recalling several versions of its eCareManager software used in hospitals for patient care. The software wasn't approved for medical use, which could pose risks to patient safety.
The eCareManager software versions listed were not approved for medical use. This means they might not function safely or correctly in hospital settings, potentially harming patients.
Healthcare facilities using Philips eCareManager software versions 4.2.1 through 4.6.0 with model number 865325 are affected. Medical staff responsible for patient care are most at risk.
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.
Look for the software version number in the device's documentation or system settings to confirm if it's affected.
The software versions were not approved for medical use, which could pose risks to patient safety.
Versions 4.2.1, 4.3.2, 4.3.3, 4.5.1, 4.5.2, and 4.6.0 with model number 865325.
The recall record does not specify a remedy, so no action is required unless you are a healthcare facility using the affected software.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0549-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0549-2022 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
