United StatesThe recalled product is PIE Medical Imaging’s 3mensio Workstation (Vascular Fenestrated) software, 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). It was recalled because user measurement values reported by the software may be larger than the actual anatomical dimension by 0.8% to 34.4% when the affected software is used, the user has access only to 3D Echo or Mitral 3D Echo, and the dataset analyzed is a Philips 3D echo dataset containing Color Doppler.
What's being recalled
3mensio Workstation (Vascular Fenestrated) software
Recalling firm: PIE Medical Imaging B.V., Maastricht, N/A, Netherlands.
How to identify it
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
The 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
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)