Product Wiki · Recalls · Health Canada — Medical Devices

BRIVO XR385 — recall 55681

Health Canada — Medical Devices · Canada · 2016-11-03 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 55681
Date of alert: 2016-11-03
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: The following issue is being addressed by GE Healthcare File No. FMI 17114: GE Healthcare has become aware of an issue with the Voltage Ratio Arc Detection (VRAD) Detectors when used during imaging in tabletop mode within a short period of time after weight is directly applied to the detector. The placing of weight on the detector can introduce image artifacts, which can result in patient exam retakes.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/brivo-xr385

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BRIVO XR385 — recall 55681

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