Recall Z-0152-2007
Hitachi Medical Systems America Inc · initiated August 14, 2006
Product
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Codes / lots: Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
Reason for recall
Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
FDA-determined 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.
Details
- Recall number
- Z-0152-2007
- Initiated
- August 14, 2006
- Posted by FDA
- November 4, 2006
- Terminated
- September 19, 2012
- Product code
- MOS – Coil, Magnetic Resonance, Specialty
- Quantity
- 1 unit
- Distribution
- The recalled unit was distributed to a single customer.
- Recalling firm
- Hitachi Medical Systems America Inc, Twinsburg, OH