Date Initiated by Firm |
August 14, 2006 |
Date Posted |
November 04, 2006 |
Recall Status1 |
Terminated 3 on September 19, 2012 |
Recall Number |
Z-0152-2007 |
Recall Event ID |
36525 |
510(K)Number |
K052172
|
Product Classification |
Magnetic Resonance Imaging Device (MRI) - Product Code MOS
|
Product |
Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150. |
Code Information |
Echelon unit Serial Number: V001. CTL coil component type : MR-CTL-150, N/N KH19636602. |
Recalling Firm/ Manufacturer |
Hitachi Medical Systems America Inc 1959 Summit Commerce Park Twinsburg OH 44087-2371
|
For Additional Information Contact |
330-425-1313
|
Manufacturer 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 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MOS and Original Applicant = HITACHI MEDICAL SYSTEMS AMERICA, INC.
|