Device product
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Z-0752-2016
Product summary
- Event
- Event 73078
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0752-2016
Official wording
Reason: 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".
Code information: Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
Distribution pattern: US Nationwide Distribution to OH and NY
Derived failure modes
-
Unknown
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".