Recall Z-3188-2018— EOS Imaging
Class II · Terminated
Class II FDA medical device recall by EOS Imaging, initiated 2018-08-01, terminated 2022-08-15. It names one FDA 510(k) clearance: K172346. Product: sterEOS workstation. 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..
- Recalling firm
- EOS Imaging
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-01
- Terminated
- 2022-08-15
- Firm location
- Paris, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.