Z-3188-2018 Class II Terminated
FDA device recall Z-3188-2018 was initiated by EOS Imaging on August 1, 2018 and is designated Class II. Reason for recall: 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. Projec… The recall status is terminated (terminated August 15, 2022). Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- August 1, 2018
- Termination Date
- August 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
sterEOS workstation
Reason for Recall
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.
Distribution Pattern
US nationwide
Code Information
All software versions are impacted