FDA Medical Device Recalls (openFDA)
Philips Medical Systems DMC GmbH: DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
- Recall number
- Z-1326-2022
- Recalling firm
- Philips Medical Systems DMC GmbH
- Product
- DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
- Status
- Open, Classified
- Initiated
- 2021-05-19
- Posted
- 2022-07-12
- Terminated
- not on file
- Reason
- Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips sent an Electronic Product Radiation Defect notification letter dated May 25, 2022 to affected customers. Philips will schedule an appointment with customers to install the software update. Philips will, without charge bring the product into compliance. Customers were instructed to complete and return the attached response form to Philips. For further information or support concerning this issue, please contact Philips Customer Care Solutions Center: 1-800-722-9377 and reference FCO71200223 for impacted DigitalDiagnost systems or FCO70600109 for impacted ProxiDiagnost systems.
- Quantity
- 140 systems in total, (Updated 1/30/2023).
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Model 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297
- 510(k) numbers
- ["K210692"]
- PMA numbers
- not on file
- Product code
- KPR
- 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