Use cautionMedical device recall · FDA · Published July 14, 2025
PIE Medical Imaging Recalls 3mensio Workstation Software for Vascular Analysis Errors
PIE Medical Imaging recalls 3mensio Workstation software versions 10.6-10.7 with clock position errors that may cause incorrect stent graft placement and tissue damage. Affected units sold from April 2024 to May 2025.
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
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Contact the company
📍Recalling firmPIE Medical Imaging B.V.Demertdwarsstraat 8A01 · Maastricht, Netherlands
“PIE Medical Imaging Recalls 3mensio Workstation Software for Vascular Analysis Errors.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51801-pie-medical-imaging-recalls-3mensio-workstation-software-for-vascular-analysis. Based on FDA recall #Z-2297-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2297-2025%22&limit=1).
The FDA announced on July 14, 2025, that PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software due to a hazard involving incorrect clock measurements. The agency stated the recall is voluntary and ongoing.
According to the FDA, when fenestrated analysis with clock measurements is started in the diagnostic bioimaging software and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position. This error may cause stent graft fenestrations at incorrect positions, which may lead to blood flow disruption and tissue damage.
Context
GovInfoNow's records show PIE Medical Imaging B.V. has 1 other recall on record since 2026-05-07. On 2026-05-07, PIE Medical Imaging issued a recall for 3mensio Workstation Software due to measurement errors in vascular imaging. Other recent recalls of similar products include Philips Azurion System Software R3.1 May Cause Imaging Loss (2025-12-12), Philips Achieva 3.0T MRI Recalled: Software Issue May Terminate Scans (2026-08-21), and Philips Allura Cardio Vascular-Allura Centron X-Ray System Recall: Unauthorized Hard Drives Cause Imaging Failure (2026-06-17).
How to tell if you have this one
Check if your software version shows 10.6 or 10.7 with the specific UDI codes listed. The software was sold between April 2024 and May 2025.
Review your software version number and UDI codes to confirm if you have an affected version (10.6 or 10.7 with specific UDI codes listed in the recall).
Contact Manufacturer
Reach out to PIE Medical Imaging for guidance on whether your software needs correction or update.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Kansas, Massachusetts, Minnesota, Mississippi, Nebraska, New Jersey, New York, North Carolina, Ohio, Texas.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2297-2025 (July 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2297-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.