sterEOS workstation recall
sterEOS workstation
Why was sterEOS workstation recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All software versions are impacted
- Product
- sterEOS workstation
- Recalling firm
- EOS Imaging
- Quantity
- 17 units
- Distribution
- US nationwide
- Recall date
- September 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)