Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 20, 2025
3mensio Workstation (Vascular Fenestrated) software
When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a …
Pie Medical Imaging B.v. recalled 3mensio Workstation (Vascular Fenestrated) software - a moderate-severity action.
3mensio Workstation (Vascular Fenestrated) software was recalled by Pie Medical Imaging B.v. in August 20, 2025. Reason: When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to m…. Check the official notice for the remedy. Verify recall #Z-2297-2025 with the FDA Devices before acting.
The recall
Pie Medical Imaging B.v. issued this moderate-severity FDA Devices recall-When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to m….
- Moderate
- severity level
- 501 units
- affected scope
- Class II
- classification
- August 20, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2297-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2297-2025) was formally reported on August 20, 2025, with the manufacturer initiating the action on July 14, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Pie Medical Imaging B.v. is listed as the recalling firm, operating out of Maastricht, N/A. Federal records list the affected scope as 501.
The documented reason for this recall is: 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 mea… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
501
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2297-2025 |
| Date reported | August 20, 2025 |
| Date initiated | July 14, 2025 |
| Recalling firm | Pie Medical Imaging B.v. |
| Firm location | Maastricht, N/A |
| Affected scope | 501 |
| Distribution | US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2297-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
3mensio Workstation (Vascular Fenestrated) software. Recalled by Pie Medical Imaging B.v.. Units affected: 501.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2297-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2297-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 20, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.