PIE Medical 3mensio Workstation software recalled for measurement accuracy errors in cardiac imaging
The 3mensio Workstation software may report heart and vessel measurements that are 0.8% to 34% larger than the actual size when specific conditions are met: the software is used with access only to 3D Echo or Mitral 3D Echo features, and the analysis involves Philips 3D echo datasets that contain Color Doppler data. This could lead to incorrect clinical measurements used in patient care decisions.
From the FDA notice · Read the official notice ↗
What to do
- If you use 3mensio Workstation version 10.7, contact PIE Medical Imaging B.V. for updated software or guidance
- Review recent cardiac measurements made under the conditions described to determine if results need clinical verification
- Do not rely solely on affected software measurements for patient diagnosis or treatment planning without additional clinical assessment
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 165
- Illnesses reported
- None reported
- Manufactured in
- Demertdwarsstraat 8A01, N/A, Maastricht, N/A, Netherlands
- Classification
- Class II
- Recall number
- Z-2767-2026
In the FDA's words
- Description
- 3mensio Workstation (Vascular Fenestrated) software 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 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 Distribution: Worldwide - US Nationwide distribution in the states of CA, NY, MN, MI, TX and the countries of United Kingdom, Australia, France, Italy, Hong Kong SAR, Thailand, Taiwan, Netherlands, Ireland, Spain, Greece, Japan, Belgium. Affected quantity: 165
- Hazard
- 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