FDAFDA · Food and drugs·Recall number Z-2339-2021
OASIS MRI System
Published September 1, 2021 · Recall initiated: July 29, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hitachi Healthcare Americas Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
- Lot
- M001-M329, M951
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.