INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
This recall has been terminated (originally issued February 9, 2016).
- Recall Initiated
- August 14, 2015
- Posted
- February 9, 2016
- Terminated
- May 18, 2016
- Recall Number
- Z-0752-2016
- Quantity
- 4
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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".
Distribution
US Nationwide Distribution to OH and NY
Lot / Code Info
Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Toshiba's planned action to bring into compliance: 1.Affected customers will be notified using the Customer Notification Letter you provided, 2. revised system software will be installed on the systems to prevent this occurrence from happening, 3. the corrections will be made free of charge, and 4. the corrections will be completed by April 4, 2016. For further questions, please call 1- 800 521-1968.