FDA Medical Device Recalls (openFDA)
Philips Healthcare: CombiDiagnost R90 is multi-functional general R/F systems.
- Recall number
- Z-0241-2022
- Recalling firm
- Philips Healthcare
- Product
- CombiDiagnost R90 is multi-functional general R/F systems.
- Status
- Open, Classified
- Initiated
- 2021-09-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 281 in total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- CombiDiagnost R90
- 510(k) numbers
- ["K203087"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28