Z-2564-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2014
- Initiation Date
- August 18, 2014
- Termination Date
- September 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 systems
Product Description
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.
Reason for Recall
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
Distribution Pattern
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.
Code Information
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.