Optima CT660 and Revolution EVO (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-67274
Affected products
A. Optima CT660
B. Revolution EVO
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
A. Optima CT660
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5454001-X
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127, Asahigaoka, 4-Chome, Hino-Shi
Tokyo
191-8503
JAPAN
B. Revolution EVO
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5454001-160
5454001-260
5454001-60
5454001-61
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127, Asahigaoka, 4-Chome, Hino-Shi
Tokyo
191-8503
JAPAN