Product Wiki · Recalls · Health Canada — Medical Devices

Syncvision System — recall 63766

Health Canada — Medical Devices · Canada · 2021-12-23 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63766
Date of alert
2021-12-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Radiology
Product type
Medical devices
Reported risk: If prior to the IFR/FFR pullback on the intrasight system, FFR measurement(s) were performed within the same syncvision procedural session, the co-registered distal value will be different than the distal value displayed in the philips IFR/FFR system. This error will appear "insufficient data, distal segment is not co-registered" the risk of suboptimal patient treatment due to falsely elevated data on the initial trendline for the IFR/FFR co-registration would be greatest from inexperienced interventionalists. Recall start date: Dec 10, 2021
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/syncvision-system

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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