PIE Medical Imaging B.V.: 3mensio Workstation (Vascular Fenestrated) software
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- PIE Medical Imaging B.V.
- Product
- 3mensio Workstation (Vascular Fenestrated) software
- Reason / 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
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-05-07
- Code info
- 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
- Product quantity
- 165
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Maastricht
- State
- N/A
- Country
- Netherlands
- Event id
- 98930
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