FDA-Device2021-09-01Class II
ECHELON Oval MRI System
Hitachi Healthcare Americas Corporation
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
Affected count
472 (US); 10 (OUS) Total
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
ECHELON Oval MRI System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2338-2021Don't want to check this manually?
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