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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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.
Part of a larger recall action
This product is one of 3 recalled by Hitachi Healthcare Americas Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Hitachi Healthcare Americas Corporation
See all →- HighMRI System Table Pads Missing Required Natural Rubber Allergen Label
FDA (Devices) · 2021-09-01
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- HighHitachi L43K intraoperative probe recall: screw cover may detach during sterilization
FDA (Devices) · 2021-08-25
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