Philips Healthcare recalls ProxiDiagnost N90 multi-functional R/F systems due to missing required radiation labels, which could lead to improper radiation exposure. Affected units may need label verification.
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 ProxiDiagnost N90 multi-functional R/F systems because some units lack required radiation labels. This could mean improper radiation exposure if the device is used without the correct labels.
The device requires specific radiation labels to meet FDA standards. Without these labels, the system might not operate safely, potentially leading to improper radiation exposure.
Healthcare facilities using Philips ProxiDiagnost N90 systems may be affected. Staff and patients using these systems without proper radiation labels could face risks.
Check for the Radiation Warning Label [21CFR 1020.30 (j)] and X-ray control certification statement [21 CFR 1010.2] on the device. The ProxiDiagnost N90 is a multi-functional general R/F system.
Check if the device has the required Radiation Warning Label and X-ray control certification statement.
Philips Healthcare found that some ProxiDiagnost N90 systems lack required radiation labels, which are needed to meet FDA electronic product radiation standards.
Check if your device has the required radiation labels. If missing, contact Philips Healthcare for guidance.
The recall addresses missing labels that could lead to improper radiation exposure, but no specific injuries have been reported.
We’ve drafted a message you can send Philips Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0240-2022 — Philips Healthcare Philips Healthcare Hello, I own a Philips Healthcare that is covered by recall Z-0240-2022 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.
