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Syncvision system
Official notice
23 Dec 2021
Last checked
23 Dec 2021
An official Health Canada notice concerns Syncvision system. 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 Published 2021-12-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63766
Official notice
2021-12-23
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Philips, Syncvision System.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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