Health product recall

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