Philips Healthcare CombiDiagnost R90 is multi-functional general R/F systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CombiDiagnost R90 is multi-functional general R/F systems.
Brand
Philips Healthcare
Lot Codes / Batch Numbers
CombiDiagnost R90
Products Sold
CombiDiagnost R90
Philips Healthcare is recalling CombiDiagnost R90 is multi-functional general R/F systems. due to The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Philips sent an Electronic Product Radiation Correction letter to inform customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Field Service Engineer will visit their site to check for the required labels and if they are missing, will resolve the issue by applying the required labels. Customers were instructed to complete and return the attached acknowledgment form to Philips DXR via email to DIFCO@philips.com. For questions contact Customer Care Solutions Center 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026