Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation.
This recall has been terminated (originally issued September 2, 2014).
- Recall Initiated
- August 18, 2014
- Posted
- September 2, 2014
- Terminated
- September 14, 2015
- Recall Number
- Z-2564-2014
- Quantity
- 39 systems
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
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.
Lot / Code Info
Product Codes: Y001, Y002, Y003, Y004, Y005, Y006, Y007, Y008, Y009, Y010, Y011, Y012, Y014, Y015, Y016, Y101, Y102, Y103, Y105, and Y951. To be updated as firm submits information.
Root Cause
Device Design
Action Taken
Letters will be sent to customers. Hatachi Serivce will be sent to each site to exchange the Gradient Coil Assembly.
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