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Hitachi Healthcare Americas Corporation recalls ECHELON MRI System
Recalled September 1, 2021 · FDA recall Z-2337-2021 · Hitachi Healthcare Americas
Hazard
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. · FDA Class II
Units
472 (US); 10 (OUS) total
Sold at
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Description
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.
Product
ECHELON MRI System
Manufacturer(s)
Hitachi Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →