Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the phy
FDA device recall Z-2564-2014 · posted 2014-09-02 · Terminated
Recall details
- Recalling firm
- Hitachi Medical Systems America Inc
- Reason for recall
- The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
- Action taken
- Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 39 systems
- Distribution
- Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, ID, KS, KY, MD, MS, NY, OH, and WY; countries of: Japan, Brazil, France, Germany, and Kyrgyzstan.
- Date initiated
- 2014-08-18
- Date posted
- 2014-09-02
- Date terminated
- 2015-09-14
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECHELON OVAL MRI SYSTEM (K113145) | Hitachi Medical Systems America, Inc. | 2012-05-01 |