DigitalDiagnost C90 Flex/Value/Chest/ER — Class II medical device recall Z-1329-2022
Ongoing recall by Philips Medical Systems DMC GmbH, reported 2022-07-20, distributed nationwide. Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstan
| Recall number | Z-1329-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Medical Systems DMC GmbH, Hamburg, Germany |
| Recall initiated | 2021-05-19 |
| Classified | 2022-07-12 |
| Reported by FDA | 2022-07-20 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | 21862105, 21862107, 21862123, 21862126, 22860027 |
| Model numbers | 712035 |
Product
DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1329-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.