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

• Reason
• Affected products

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