PIE Medical Imaging recalls specific versions of 3mensio Workstation software for vascular imaging due to potential overestimation of cardiovascular measurements by up to 34.4% in certain use cases.
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
PIE Medical Imaging has recalled specific versions of their 3mensio Workstation software for vascular imaging. The software may report measurements that are up to 34.4% larger than actual anatomical dimensions when used with Philips 3D echo datasets containing color Doppler information.
The software may report measurements that are 0.8% to 34.4% larger than actual anatomical dimensions when used with specific Philips 3D echo datasets containing color Doppler information. This could lead to inaccurate medical decisions if the measurements are used for patient treatment planning.
Users of the recalled software versions who analyze Philips 3D echo datasets with color Doppler information are most at risk. This primarily affects medical professionals using cardiovascular imaging systems.
Check for software versions 10.7 with specific UDIs listed in the recall notice. The affected versions include SP1 through SP5 updates for the 3mensio Workstation (Vascular Fenestrated) software.
Verify your software version against the listed UDIs in the recall notice to confirm if it is affected.
The software may report measurements that are up to 34.4% larger than actual anatomical dimensions when used with specific Philips 3D echo datasets containing color Doppler information.
Software versions 10.7 with specific UDIs: (01)08056304455925(11)250423(8012)10.7, (01)08056304455925(11)250523(8012)10.7 SP1, (01)08056304455925(11)250714(8012)10.7 SP2, (01)08056304455925(11)250729(8012)10.7 SP3, (01)08056304455925(11)251016(8012)10.7 SP4, (01)08056304455925(11)251103(8012)10.7 SP5.
Check your software version against the listed UDIs in the recall notice to confirm if it is affected.
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-2767-2026 — PIE Medical Imaging PIE Medical Imaging Hello, I own a PIE Medical Imaging that is covered by recall Z-2767-2026 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.
