SYNGO.VIA (2018-01-11)

Starting date:

January 11, 2018

Posting date:

January 29, 2018

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-65804

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  Reason
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  Affected products

Affected products

SYNGO.VIA

Reason

The manufacturer has identified a limitation within the syngo.via VB20A reporting sections. After entering the findings information using the findings assistant or the Interactive Findings Dialogue (IFD), user may check the finding information within the report. In case a correction of finding information should be needed, user does the correction in "findings information" section or "summary of measured findings" section. In VB20A versions listed, this feature is not working as expected: the corrected values modified in the report are neither saved, nor printed, nor sent to information system. The system will still use the former values. If the late modifications done on the syngo.via evidence report are not noticed later when creating the formal report in the reporting system, outdated information could be sent to the referring physician.

Affected products