INFX-8000V Bi-Plane X-Ray Interventional System X-ray recall: Software Issue
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Why was INFX-8000V Bi-Plane X-Ray Interventional System X-ray 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".
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
- Product
- INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 4
- Distribution
- US Nationwide Distribution to OH and NY
- Recall date
- February 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)