DigitalDiagnost 4 High Performance. radiography and fluoroscopy system Recall
Issued July 20, 2022 · Philips Medical Systems DMC GmbH
In July 2022, Philips Medical Systems DMC GmbH recalled the DigitalDiagnost 4 High Performance. radiography and fluoroscopy system, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using DigitalDiagnost 4 High Performance. radiography and fluoroscopy system right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips Medical Systems DMC GmbH to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Philips Medical Systems DMC GmbH
- Category
- Health
- Recall date
- July 20, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide Distribution
- Recall number
- FDA-Z-1326-2022
- Made in
- Germany
- Issuing agency
- FDA
In context
- Philips Medical Systems DMC GmbH has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.