OPTIMA MR430S 1.5T - MAIN UNIT (2016-05-13)

Starting date:
May 13, 2016
Posting date:
May 30, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals, Healthcare Professionals, General Public
Identification number:
RA-58618

Affected products

A. OPTIMA MR430S 1.5T - MAIN UNIT

Reason

GE Healthcare has recently become aware of a potential safety issue with gas venting. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients. There have been no injuries reported as a result of this issue.
At this site, a magnet heater probe connection became disconnected. This resulted in ice build-up within the magnet blocking the cryogen vent. Since the vent was blocked by ice, the later magnet quench caused gas to be vented into the magnet room.

Affected products

A. OPTIMA MR430S 1.5T - MAIN UNIT

Lot or serial number

0004212012-001

Model or catalog number

OPTIMA MR430S 1.5T (5000-0002)

Companies
Manufacturer
GE Medical Systems, LLC
301 BALLARDVALE ST., SUITE 4
WILMINGTON
01887
Massachusetts
UNITED STATES