Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150.
FDA device recall Z-0152-2007 · posted 2006-11-04 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
- Action taken
- 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
- Status
- Terminated
- Product code
- MOS
- Quantity affected
- 1 unit
- Distribution
- The recalled unit was distributed to a single customer.
- Date initiated
- 2006-08-14
- Date posted
- 2006-11-04
- Date terminated
- 2012-09-19
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HHF1 MAGNETIC RESONANCE IMAGING SYSTEM (K052172) | Hitachi Medical Systems America, Inc. | 2005-09-27 |