FDA (Devices) recall action 88452
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.
Hitachi Healthcare Americas has recalled OASIS MRI System table pads due to missing labels and user manual notification about dry natural rubber content. The missing notification violates federal labeling requirements for this latex allergen.
Hitachi Healthcare Americas is recalling ECHELON MRI System table pads because packaging and user manuals lack required disclosure that the pads contain dry natural rubber, a potential allergen. No illnesses have been reported.