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SIGNA PIONEER (2016-03-03)
- Starting date:
- March 3, 2016
- Posting date:
- March 17, 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-57568
Affected Products
A. SIGNA PIONEER
Reason
GE Healthcare has recently become aware of a potential safety issue with a missing ferrous warning label on SIGNA Pioneer table control box (TCB). Ferrous material in the TCB could cause unexpected attraction to the MR system's high-strength magnetic field during servicing activities. This could create a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field. There have been no events reported as a result of this issue. Clinical scanning of patients is not affected by this safety notification.
Affected products
A. SIGNA PIONEER
Lot or serial number
001719TA4
Model or catalog number
SIGNA PIONEER
Companies
- Manufacturer
-
GE Healthcare Japan Corporation
7-127 Asahigaoka, 4 Chome, Hinoshi
Tokyo
191-8503
JAPAN