3mensio Workstation — Class II medical device recall Z-2767-2026
Ongoing recall by PIE Medical Imaging B.V., reported 2026-07-29, distributed nationwide. User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular
| Recall number | Z-2767-2026 |
|---|---|
| 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 | 2026-05-07 |
| Classified | 2026-07-21 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, ES, FR, GB, GR, HK, IE, IT, JP, NL, TH, TW |
| Quantity | 165 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 08056304455925 |
Product
3mensio Workstation (Vascular Fenestrated) software
Reason for recall
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
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-2767-2026. 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.