3mensio Workstation — Class II medical device recall Z-2297-2025
Ongoing recall by PIE Medical Imaging B.V., reported 2025-08-20, distributed nationwide. When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to me
| Recall number | Z-2297-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | PIE Medical Imaging B.V., Maastricht, N/A, Netherlands |
| Recall initiated | 2025-07-14 |
| Classified | 2025-08-12 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 501 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 08056304455505, 08056304455925 |
Product
3mensio Workstation (Vascular Fenestrated) software
Reason for recall
When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
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-2297-2025. 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.