FDA Device

Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.

Hazard

Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.

What You Should Do

Remedy

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.

Products

Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Brand
Hitachi Medical Systems America Inc
UPC
Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.

Units Affected

1 unit