Optima CT660 & Revolution EVO (2019-12-18)
- Starting date:
- December 18, 2019
- Posting date:
- January 10, 2020
- 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-72077
Last updated: 2020-01-10
Affected Products
- Optima CT660
- Revolution EVO
Reason
GE Healthcare has become aware of a potential issue during the use of the smartprep feature on Revolution EVO, Optima CT660, and Optical CT680 systems. This issue could cause additional radiation exposure if the system software options are loaded improperly.
Affected products
-
Optima CT660
Lot or serial number
- 00000430797CN1
- 434751CN4
- 436686CN0
- 437801CN4
- 438486CN3
- G56587171P1
Model or catalog number
OPTIMA CT660
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127 Asahigaoka, 4 Chome, Hinoshi
Tokyo
191-8503
JAPAN
B. Revolution EVO
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
REVOLUTION EVO
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127 Asahigaoka, 4 Chome, Hinoshi
Tokyo
191-8503
JAPAN