Optima CT540 Series CT Scanner System (2018-04-27)
- Starting date:
- April 27, 2018
- Posting date:
- July 19, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67276
Affected products
Optima CT540 Series CT Scanner System
Reason
The following issue is being addressed by GE healthcare file no. FMI 26859: GE healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC (volts alternating current) to service engineers working inside the gantry. This issue does not affect patients or operators external to the equipment.
Affected products
Optima CT540 Series CT Scanner System
Lot or serial number
00000332406HM8
CBAQG1600070HM
CBAQG1700017HM
Model or catalog number
5432539
Companies
- Manufacturer
-
GE Hangwei Medical Systems Co. Ltd.
WEST AREA OF BLDG. NO.3, NO.1 YONGCHANG NORTH ROAD, BEIJING, ECONOMIC & TECHNOLOGICAL DPVMT ZONE
Beijing
100176
CHINA