Philips Healthcare recalls CombiDiagnost R90 medical devices due to missing required radiation labels, which could affect safety compliance. Affected units may need verification of labels.
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
Philips Healthcare is recalling CombiDiagnost R90 multi-functional medical devices because some units lack required radiation labels. This could lead to safety compliance issues if the labels are missing, though it doesn't pose an immediate risk to users.
The devices require specific radiation labels and certification statements to meet FDA safety standards. Missing these labels could result in non-compliance with radiation safety regulations, potentially affecting device safety.
Medical facilities using Philips CombiDiagnost R90 systems may be affected. Staff handling these devices are most at risk if labels are missing.
Check for missing Radiation Warning Labels or X-ray control certification statements on the device. The CombiDiagnost R90 is a multi-functional medical device sold by Philips Healthcare.
Check if the device has the required Radiation Warning Label and X-ray control certification statement.
Philips Healthcare determined that some CombiDiagnost R90 systems lack required radiation labels, which are needed for compliance with FDA safety standards.
No, the recall does not require stopping use. Affected units should check for missing labels.
Check for the missing Radiation Warning Label or X-ray control certification statement on the CombiDiagnost R90 device.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0241-2022 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0241-2022 from Philips Healthcare. 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.
