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BRIVO XR385
- Starting date:
- October 18, 2016
- Posting date:
- November 3, 2016
- 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-60806
Affected Products
Reason
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.
Affected products
BRIVO XR385
Lot or serial number
- BRIVO XR385
Model or catalog number
- 000A1E4CN077P1
- 000A1E4CN077R2
- 000A1E5AN059K1
Companies
- Manufacturer
-
GE Hualun Medical Systems Co. Ltd.
No.1 Yong Chang North Road,, Beijing Economic Technological, Development Zone,
Beijing
100176
CHINA