OASIS MRI table pads recalled for missing latex allergen labeling
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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II FDA recall for missing labeling of a latex allergen in medical device table pads. No illnesses or injuries reported. The hazard is allergen-related but the issue is purely labeling non-compliance without documented incidents.
Plain-English summary
The OASIS MRI System table pads contain dry natural rubber but lacked required labeling on the pad packaging and notification in the user manual about this content. This absence violates 21 CFR 801.437, which requires disclosure of dry natural rubber (latex allergen).
The recall affects approximately 472 units in the United States and 10 units distributed in Mexico and Brazil. Dry natural rubber is a latex allergen that may cause allergic reactions in sensitive individuals.
Users should review their OASIS MRI System documentation and contact Hitachi Healthcare Americas Corporation for information about obtaining proper labeling or replacement pads if needed.
The recalled product
- Product
- OASIS MRI System
- Manufacturer
- Hitachi Healthcare Americas Corporation
- Hazard
- latex-allergen
- missing-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- M001-M329
- M951
Distribution
Distributed nationwide across the United States.
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