Recall Z-3188-2018 ยท LLZ System, Image Processing, Radiological
EOS Imaging
sterEOS workstation
| Date | Aug 1, 2018 |
| Status | Terminated |
| Reason | 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions. |
| Root cause | Software design |
| Action | On August 1, 2018, a Field Safety Notice was issued to all impacted customers. Measures to be taken by users: EOS system and sterEOS review workstation users are requested not to apply manual symmetry to an image before saving a 2D secondary capture if more than two images are displayed in the EOS viewer mode or in 2D sterEOS. Users of the 3D sterEOS review workstation are requested to check that 3D projections associated with pelvic parameters match when a 3D image is created from a pair of images belonging to a series of more than two images. INSTRUCTIONS FOR END USERS: 1) Please read t |
| Quantity | 17 units |
| Distribution | US nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172346 | sterEOS Workstation Eos Imaging, Jun 19, 2018 |