Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
FDA Recall Z-0152-2007 · Posted 2006-11-04
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeMOS
Date Initiated2006-08-14
Date Terminated2012-09-19
Product Quantity1 unit
Reason for Recall
Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
Firm Action
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.
Root Cause
Other
Distribution Pattern
The recalled unit was distributed to a single customer.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.