Z-0152-2007

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

Name: Z-0152-2007 Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type...
Creator: Hitachi Medical Systems America Inc
Published: 2006-08-14
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-08-14 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150 on 2006-08-14. The reason FDA records is "Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0152-2007
Status: Terminated
Initiated: 2006-08-14
Posted: 2006-11-04
Terminated: 2012-09-19
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
FDA root cause: Other
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.
Quantity in commerce: 1 unit
Distribution: The recalled unit was distributed to a single customer.
Product codes and lots: Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602.

Product code MOS

K052172Class IIHhf1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. / cleared 2005-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)