Product Wiki · Recalls · Health Canada — Medical Devices

Brivo XR385 Digital Diagnostic System — recall 48318

Health Canada — Medical Devices · Canada · 2013-01-21 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
48318
Date of alert
2013-01-21
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: A software issue has been identified internally that allows users to take exposures while the error screen is displayed. This causes a pop-up protocol selection correction window to be presented to the user covering the techniques. This situation is not compliant with IEC 60601-1-3 Clause 6.4.3.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/brivo-xr385-digital-diagnostic

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