3mensio Workstation (Vascular Fenestrated) software
PIE Medical Imaging B.V.
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 FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
3mensio Workstation (Vascular Fenestrated) software
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model (01)08056304455925(11)250523(8012)10.7 SP1Model (01)08056304455925(11)250714(8012)10.7 SP2Model (01)08056304455925(11)250729(8012)10.7 SP3Model (01)08056304455925(11)251016(8012)10.7 SP4Model (01)08056304455925(11)251103(8012)10.7 SP5UPC 08056304455925Would you have heard about this one?
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