Public recall detail

Syncvision System

medium
Recall Safety notice
Quick summary

Quick summary: Syncvision System.

Recommended action

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Recall details

Quick summary: Syncvision System.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandPhilips Electronics Ltd.
ProductSyncvision System
IssueMedical devices - Inaccurate test or measurement results
Recall classType II
IdentificationRA-63766

Affected products

ProductSyncvision System
LotNot applicable
Model400-0100.10
Serial numberNot applicable
DescriptionSyncvision System

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Radiology
CompaniesCompany: Philips Electronics Ltd. 1875 Buckhorn Gate, Mississauga, Ontario Canada, L4W 5P1 Company: Volcano Corporation 3721 Valley Centre Drive, Suite 500, San Diego, California United States, 92130
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-63766
Background{}
CompaniesCompany: Philips Electronics Ltd. 1875 Buckhorn Gate, Mississauga, Ontario Canada, L4W 5P1 Company: Volcano Corporation 3721 Valley Centre Drive, Suite 500, San Diego, California United States, 92130
AudiencesGeneral public Health professionals Hospitals
Source updated2021-12-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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