Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging B.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PIE Medical Imaging B.V. · Demertdwarsstraat 8A01 · Maastricht
Is this the product you have?
- 3mensio Workstation (Vascular Fenestrated) software
- Lot codes and dates
- Software Version 10.7
- 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
- Amount recalled
- 165
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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