Recall record at a glance
| Official record | Z-2297-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | PIE Medical Imaging B.V. |
| Report date | Aug 20, 2025 |
| Recall initiation date | Jul 14, 2025 |
| Quantity | 501 |
| Location | Maastricht, N/A, Netherlands |
Official product description
3mensio Workstation (Vascular Fenestrated) software
Why the product was recalled
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
Distribution information
US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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