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.
Take action
Contact the company
📍Recalling firmPhilips Healthcare3000 Minuteman Rd · Andover, MA 01810-1032
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/61776-philips-combidiagnost-r90-missing-radiation-labels-risk-safety.
“Philips CombiDiagnost R90: Missing Radiation Labels Risk Safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61776-philips-combidiagnost-r90-missing-radiation-labels-risk-safety. Based on FDA recall #Z-0241-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0241-2022%22&limit=1).
The FDA announced on 2021-09-22 that Philips Healthcare is recalling CombiDiagnost R90 multi-functional general R/F systems due to missing required radiation warning labels. The agency stated the recall addresses compliance with FDA Electronic Product Radiation Control performance standards.
How to tell if you have it
Brand: Philips Healthcare
Product: CombiDiagnost R90
Quantity: 281 units
The hazard
The recall concerns the Aleva monitor, which requires specific labels mandated by FDA Electronic Product Radiation Control performance standards. Philips determined that some systems at customer locations lacked the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2].
Context
GovInfoNow's records show Philips Healthcare has had six other recalls since 2018-06-11. Recent brand recalls include the 2023-08-02 Philips Incisive CT Software 5.0 Recall and the 2022-02-02 Philips StentBoost Live R2.0 recall. Other recent recalls of similar products include the 2025-10-24 GE Medical Systems Senographe Pristina Mammography Machines recall for missing X-Ray warning labels and the 2026-08-07 Philips Brilliance CT 64 Medical Scanner recall for unintended radiation risk.
How to tell if you have this one
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.
Brand
Philips Healthcare
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide Distribution
Recall number
Product, codes & lots
Z-0239-2022
DigitalDiagnost C90; DigitalDiagnost C90
Z-0240-2022
ProxiDiagnost N90 is multi-functional general R/F systems.; ProxiDiagnost N90
Z-0241-2022
CombiDiagnost R90 is multi-functional general R/F systems.; CombiDiagnost R90
Based on the official FDA remedy
What to do — step by step
Verify Labels
Check if the device has the required Radiation Warning Label and X-ray control certification statement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0241-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0241-2022 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.