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Brivo XR385 Digital Diagnostic System
- Starting date:
- December 19, 2012
- Posting date:
- January 21, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-16829
Recalled Products
- Brivo XR385 Digital Diagnostic System
Reason
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.
Affected products
A. Brivo XR385 Digital Diagnostic System
Lot or serial number
N/A
Model or catalog number
BRIVO XR385
Companies
- Manufacturer
- GE Hualun Medical Systems Co. Ltd.