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Optima MR360 Main Unit (2014-12-29)
- Starting date:
- December 29, 2014
- Posting date:
- January 7, 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-43165
Recalled Products
Optima MR360 Main Unit
Reason
Magnet Rundown Unit (MRU) may not be connected to the magnet. If the MRU is disconnected, the MRU will not function as expected and will not quench the magnet when the button is pressed. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
Affected products
Optima MR360 Main Unit
Lot or serial number
403541MR
450670MR2
604985MR1
AM12O9T240
AM12O9T294
Model or catalog number
5312366 (M50002BB)
Companies
- Manufacturer
-
GE Hangwei Medical Systems Co. Ltd.
No. 2 North Yong Chang Street, Beijing Economic, Technological Development Zone,
Beijing
100176
CHINA