Philips Healthcare recalls DigitalDiagnost C9: Some units lack required radiation labels, posing risks for medical use. Check if your device has missing labels and contact Philips for details.
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 some DigitalDiagnost C90 medical monitors because they may not have required radiation labels. This could lead to improper use in medical settings where radiation safety is critical.
The monitors require specific radiation labels to meet FDA safety standards. Without these labels, the device might not function correctly in medical settings, potentially exposing users to unnecessary radiation.
Healthcare providers using Philips DigitalDiagnost C90 monitors are most at risk. Patients and staff could be exposed to radiation if the device is used without proper labeling.
Check if your DigitalDiagnost C90 monitor has the Radiation Warning Label [21CFR 1020.30 (j)] and X-ray control certification statement [21 CFR 1010.2]. These labels are required by FDA regulations.
Look for the Radiation Warning Label [21CFR 1020.30 (j)] and X-ray control certification statement [21 CFR 1010.2] on your DigitalDiagnost C90 monitor.
Philips Healthcare found that some DigitalDiagnost C90 monitors did not have required radiation labels, which are needed to meet FDA safety standards.
No, but you should check if your monitor has the required radiation labels. If missing, contact Philips for guidance.
Contact Philips Healthcare directly to get instructions on how to address the missing labels.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0239-2022 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0239-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
