EOS Imaging Recalls sterEOS Workstation Due to 3D Projection Errors
EOS Imaging is recalling 17 sterEOS workstations because 3D projections may be incorrect when using specific secondary image captures, potentially leading to clinical errors.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, but incorrect clinical decisions or sub-optimal surgical interventions are possible.
Plain-English summary
EOS Imaging is recalling 17 units of the sterEOS workstation. The recall is due to a software issue where 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, and one of the images has been manually flipped.
These projection errors may lead to errors in the calculation of 3D clinical parameters when adjusting the position, size, and shape of 3D objects. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions or sub-optimal surgical interventions.
The recall covers all software versions of the product and is distributed US nationwide. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- sterEOS workstation
- Manufacturer
- EOS Imaging
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All software versions are impacted
Distribution
Distributed nationwide across the United States.
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