Reported Sep 10, 2014 · Terminated
Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the…
Hitachi Medical Systems America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- 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.
- Lot codes and dates
- Product CodesY001, 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
- Amount recalled
- 39 systems
Where it was sold
Why it was recalled
The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard.
This product could cause temporary or reversible health problems — stop using it.
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