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Definium 5000 Digital Radiographic Imaging 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-16897
Recalled Products
- Definium 5000 Digital Radiographic Imaging System
Reason
Recall was due to a software issue. When a user quickly switches the protocols from AEC to Fixed under the same view and if the user selection process time is less than 0.5 seconds, the ui may display different exposure techniques than selected. The exposure can still be made as commanded, however it may not be properly indicated.
Affected products
A. Système d'imagerie radiographique numérique Definium 5000
Lot or serial number
Not Applicable.
Model or catalog number
5220493-2
Companies
- Manufacturer
- GE Medical Systems, LLC.