Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
This recall has been terminated (originally issued November 4, 2006).
- Recall Initiated
- August 14, 2006
- Posted
- November 4, 2006
- Terminated
- September 19, 2012
- Recall Number
- Z-0152-2007
- Quantity
- 1 unit
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
Distribution
The recalled unit was distributed to a single customer.
Lot / Code Info
Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
Root Cause
Other
Action Taken
The recalling firm issued a Device Correction letter to the clinic customer on 9/15/2006 making them aware of this potential problem and of their completed corrective action on 8/14/2006, by a Service Rep visit.
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