RTVUE OCT SCANNER (2016-04-18)

Starting date:

April 18, 2016

Posting date:

May 20, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58528

• Reason
• Affected products

Affected products 

A. RTVUE OCT SCANNER

Reason

A minor software upgrade for Optovue device families were released on February 22, 2016. The device families are the iVue (RTVue - iVue100), iFusion and iFue500 (iScan in the US). The software configuration is 2016.1.0.127 (outside the US only). The device user will perform a scan of a patient's retina. They may then review the data within a series of available reports. Two reports are affected by the software anomaly: (1) retina map OU report and (2) iWellness OU report. For example, in the new retina map OU report, the user may scroll on the “map" or the "B-scan" image of either eye. This activates the software anomaly and makes both B-scans identical (i.e. - both show the same eye). Whether both eyes become left or right depends on how you enter the report. For example, entering the OU report from the OD (right eye) report will cause both B-scans to be right eye when scrolling is attempted.

Affected products