Reported Mar 12, 2014 · Terminated
TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
Toshiba American Medical Systems Inc.
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: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
- Lot codes and dates
SERIAL NO.: 1CB12620061DB13120331DC13520701DB13420601DB13320491DC13820811DB13120271DB13320451DC13620731CB12X2018
- Amount recalled
- 8 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed.
This product could cause temporary or reversible health problems — stop using it.
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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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