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
PIE Medical Imaging recalls specific software versions of their 3mensio Workstation for vascular imaging. The software may misplace stent grafts during analysis, potentially causing blood flow disruption and tissue damage if clock positions are changed incorrectly.
When a user changes the 12-hour clock position in the software during vascular analysis, other clock measurements may not update correctly. This can cause stent grafts to be placed at incorrect positions, potentially disrupting blood flow and damaging tissues.
Medical professionals using the 3mensio Workstation software for vascular imaging are most at risk. Patients receiving procedures with this software could be affected if the software misplaces stent grafts.
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).
Reach out to PIE Medical Imaging for guidance on whether your software needs correction or update.
Software versions 10.6 and 10.7 with specific UDI codes listed in the recall, sold between April 2024 and May 2025.
The recall states that incorrect stent graft placement may lead to blood flow disruption and tissue damage, but the remedy does not specify immediate action to prevent injury.
Check your software version and UDI codes against the specific codes listed in the recall (10.6 or 10.7 with the provided UDI codes).
We’ve drafted a message you can send PIE Medical Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-2297-2025 — PIE Medical Imaging PIE Medical Imaging Hello, I own a PIE Medical Imaging that is covered by recall Z-2297-2025 from PIE Medical Imaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
