Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OASIS MRI System Recalled by Hitachi Healthcare Americas Corporation Due to There was no label on the pad packaging...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Healthcare Americas Corporation directly.
Affected Products
OASIS MRI System
Quantity: 472 (US); 10 (OUS) Total
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hitachi Healthcare Americas Corporation
Hitachi Healthcare Americas Corporation has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report