FDA Medical Device Recalls (openFDA)
Philips Medical Systems Gmbh, DMC: CombiDiagnost R90 Software Version R1.0 and R1.1
- Recall number
- Z-2357-2021
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Product
- CombiDiagnost R90 Software Version R1.0 and R1.1
- Status
- Open, Classified
- Initiated
- 2020-07-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips sent customers an Electronic Product Radiation Correction letter dated July 14, 2021. The letter identified the affected product, problem and actions to be taken. Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. For questions contact the Customer Care Solutions Center 1-800-722-9377 and reference FCO70900051.
- Quantity
- 322 systems; 66 in US
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model 706100
- 510(k) numbers
- ["K203087"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 3003768251
- Firm city
- Hamburg
- Firm state
- not on file
- Firm country
- Germany
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