Reported Feb 17, 2016 · Terminated
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
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?
- INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Lot codes and dates
Serial Numbers ACA1492002AAA1492001W4B1442020and W4B1432018
- Amount recalled
- 4
Where it was sold
Why it was recalled
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
This product could cause temporary or reversible health problems — stop using it.
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