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 |
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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.
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510(K) Database | 510(K)s with Product Code = MOS
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