DigitalDiagnost 4 Flex / Value. radiography and recall
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Why was DigitalDiagnost 4 Flex / Value. radiography and recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 712032 Serial Numbers - 10001088 10001097 10001104 10001112 19000317 10001095 10001102 10001105
- Product
- DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
- Recalling firm
- Philips Medical Systems DMC GmbH
- Quantity
- 140 systems in total, (Updated 1/30/2023).
- Distribution
- US Nationwide Distribution
- Recall date
- July 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)