Hitachi Healthcare Americas Corporation recalls ECHELON Oval MRI System
Recalled Product
ECHELON Oval MRI System
Hazard / Issue
There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Y001-Y016, Y051-Y068, Y101-Y169, Y951
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