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Health Canada Medical devices

Ortho Optix™ Reader

Issued August 22, 2022
Issue
On the Ortho Optix Reader, when reviewing the results, the user can edit a grade and/or analysis of the results. • When performing this action, the user may also choose to "cancel" the edit. •Wwhen cancelling the edit, the user is informed that the "changes have not been saved" via a user interface prompt, which the user must "acknowledge/accept". • After the user "accepts", the result displayed on the user interface reverts as expected back to the original result and awaits result approval. • However, when the user completes "result approval", the result that is unexpectedly stored in the database and reported out of the system (such as to a connected lis) is the "edited result" that was previously cancelled. When this anomaly occurs, there is potential for an erroneous result to be stored in the database and reported out of the system. Recall start date: August 12, 2022
Hazard description
Performance
Product
Product name
Ortho Optix™ Reader
Reference
ID
RA-64491