Class II — PIE Medical Imaging B.V.
| Recalling firm | Pie Medical Imaging B.V. |
|---|---|
| Registered facility | PIE MEDICAL IMAGING B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | 3mensio Workstation (Vascular Fenestrated) software |
| Quantity | 501 |
| Distribution | US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC. |
| Initiated | 2025-07-14 |
| Classified | 2025-08-12 |
| Recall number | Z-2297-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PIE Medical Imaging B.V. (Z-2297-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97307/
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