FDAFDA · Food and drugs·Recall number Z-2564-2014
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.
Published September 10, 2014 · Recall initiated: August 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hitachi Medical Systems America Inc
- Distributor
- 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
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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