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1.5T SIGNA HDX MR SYSTEM - MAIN UNIT (2015-07-16)
- Starting date:
- July 16, 2015
- Posting date:
- July 29, 2015
- 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-54448
Affected Products
A.1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
Reason
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
Affected products
A.1.5T SIGNA HDX MR SYSTEM - MAIN UNIT
Lot or serial number
282692MR3
HDMR3905
Model or catalog number
M3335J
Companies
- Manufacturer
-
GE Medical Systems, LLC
3000 North Grandview Blvd.
Waukesha
53188
Alabama
UNITED STATES