Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CombiDiagnost R90 is multi-functional general R/F systems. Recalled by Philips Healthcare Due to The Aleva monitor requires certain labels to be...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare directly.
Affected Products
CombiDiagnost R90 is multi-functional general R/F systems.
Quantity: 281 in total
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Healthcare
Philips Healthcare has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report