Reported Mar 29, 2017 · Terminated
Hitachi Echelon Oval MRI System
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
- Lot codes and dates
Y001Y002Y003Y004Y005Y006Y007Y008Y009Y010Y011Y012Y013Y014Y015Y016Y101Y102Y103Y104Y105Y106Y107Y108Y951
- Amount recalled
- 25 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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