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MSK Extreme and Optima MR430S 1.5T MRI Systems (2015-03-02)
- Starting date:
- March 2, 2015
- Posting date:
- March 20, 2015
- 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-52609
Recalled Products
A) MSK Extreme
B) Optima MR430S 1.5T - Main Unit
Reason
The latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. The most recently deployed on-site software version may include safety updates.
Affected products
A) MSK Extreme
Lot or serial number
905521ONI
Model or catalog number
Not applicable
Companies
- Manufacturer
-
GE Medical Systems, LLC
301 BALLARDVALE ST., SUITE 4
WILMINGTON
01887
Massachusetts
UNITED STATES
B) Optima MR430S 1.5T - Main Unit
Lot or serial number
514697ONI
Model or catalog number
Sans objet
Companies
- Manufacturer
-
GE Medical Systems, LLC
301 BALLARDVALE ST., SUITE 4
WILMINGTON
01887
Massachusetts
UNITED STATES