FDAFDA · Food and drugs·Recall number Z-0752-2016
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Published February 17, 2016 · Recall initiated: August 14, 2015
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
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".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Toshiba American Medical Systems Inc
- Distributor
- US Nationwide Distribution to OH and NY
- Lot
- Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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