Hitachi Medical Systems America Inc Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
Products Sold
Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.
Hitachi Medical Systems America Inc is recalling Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil typ due to Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026