Reported Sep 1, 2021 · Terminated
OASIS MRI System
Hitachi Healthcare Americas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Healthcare Americas Corporation · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- OASIS MRI System
- Lot codes and dates
M001-M329M951
- Amount recalled
- 472 (US); 10 (OUS) Total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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