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Proteus XR/A General Purpose Radiographic System and Precision 500D System (2014-01-27)
- Starting date:
- January 27, 2014
- 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-38545
Recalled Products
A. Proteus XR/A General Purpose Radiographic System
B. Precision 500D System
Reason
Intermittently when a large number of patient exams are retrieved from the HIS/RIS system, the exams are improperly displayed. If the user continues to attempt to select one of the exams when this issue has occurred the system will update the screen, and in doing so potentially select a different exam/patient. If the user does not notice this change and continues to perform the exam, the images will be placed in an incorrect patient file.
Affected products
A. Proteus XR/A General Purpose Radiographic System
Lot or serial number
S3918JA
Model or catalog number
00000094745HL7
Companies
- Manufacturer
-
GE Hualun Medical Systems Co. Ltd.
No.1 Yong Chang North Road,, Beijing Economic Technological, Development Zone,
Beijing
100176
CHINA
B. Precision 500D System
Lot or serial number
S0915KE
Model or catalog number
00000080557HL2
Companies
- Manufacturer
-
GE Hualun Medical Systems Co. Ltd.
No.1 Yong Chang North Road,, Beijing Economic Technological, Development Zone,
Beijing
100176
CHINA