EOSedge imaging device (2020-12-29)
- Starting date:
- December 29, 2020
- Posting date:
- January 15, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74763
Last updated:
2021-01-15
Affected Products
EOSedge imaging device
Reason
When the operator performs a biplanar acquisition (frontal and lateral simultaneously) with Eosedge system, with patient orientation different from AP (antero-posterior) and when user manually adjusts at least one reference plane position at the 'review' step, resulting images are not properly resized. 2D measurements made on these images may be incorrect.
Affected products
EOSedge imaging device
Lot or serial number
All lots.
Model or catalog number
3663999000108
Companies
- Manufacturer
-
EOS IMAGING
10, RUE MERCOEUR
PARIS, FRANCE
75011