Product Wiki · Recalls · Health Canada — Medical Devices

Cadstream — recall 55965

Health Canada — Medical Devices · Canada · 2016-08-26 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 55965
Date of alert: 2016-08-26
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: This recall has been initiated due to a necessary modification to the Cadstream difference threshold when Cadstream is used in conjunction with the GE Phased Array Uniformity Enhancement (Pure) for dynamic MRI imaging and a lack of notification when Cadstream detects the pure filter has been used.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cadstream-0

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Cadstream — recall 55965

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