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Signa Creator and Signa Explorer
- Starting date:
- August 31, 2016
- 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-60250
Affected Products
- SIGNA Creator
- SIGNA Explorer
Reason
The following issue is being addressed by GE Healthcare file no. FMI 67921: GE Healthcare has become aware of an issue involving two power monitor failures. These two failures together, could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
Affected products
A. SIGNA Creator
Lot or serial number
002949TA6
Model or catalog number
6433265-1
Companies
- Manufacturer
-
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
NO. 266 JINGSAN ROAD
TIANJIN
300308
CHINA
B. SIGNA Explorer
Lot or serial number
003793TA7
Model or catalog number
6433266-1
Companies
- Manufacturer
-
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
NO. 266 JINGSAN ROAD
TIANJIN
300308
CHINA