Reported Oct 12, 2016 · Terminated
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
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 · PO Box 2068 · Tustin, CA · 92780-7047
Is this the product you have?
- Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
- Lot codes and dates
- LL 500
- Amount recalled
- 165
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
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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