The EOSedge system may acquire two simultaneous recall
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by…
Why was The EOSedge system may acquire two simultaneous recalled?
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
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?
Product Reference:03663999000108; Serial Numbers: 8.1912.1008, 8.2001.1010, 8.2001.1011, 8.2002.1012, 8.1907.1005, 8.1909.1006, 8.2005.1014, 8.1905.1004, 8.1911.1007, 8.1912.1009, and 8.2006.1016
- Product
- The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by…
- Recalling firm
- EOS Imaging
- Quantity
- 11 devices
- Distribution
- Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France
- Recall date
- April 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)