OASIS MRI System recall
OASIS MRI System
Why was OASIS MRI System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
M001-M329, M951
- Product
- OASIS MRI System
- Recalling firm
- Hitachi Healthcare Americas Corporation
- Quantity
- 472 (US); 10 (OUS) Total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)