steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software versions: 1.3, 1.4 and 1.5
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- EOS Imaging
- Reason for Recall:
- Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Product Codes/Lot Numbers:
Software versions: 1.3, 1.4 and 1.5
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0580-2014
Related Recalls
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
sterEOS workstation
EOS Imaging
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.
ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.