Recall Z-0752-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Toshiba American Medical Systems Inc
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
| Date | Feb 9, 2016 (initiated Aug 14, 2015) |
| Status | Terminated |
| 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". |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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. |
| Quantity | 4 |
| Distribution | US Nationwide Distribution to OH and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120073 | INFX-8000V WITH Toshibamedical Systems Corporation, Jan 26, 2012 |
| K133535 | INFX-8000V, V5.30 Toshibamedical Systems Corporation, Jul 23, 2014 |
| K143225 | INFX-8000V with Wireless Footswitch Toshibamedical Systems Corporation, Jan 9, 2015 |
| K152696 | INFX-8000V, V6.20 Toshibamedical Systems Corporation, Jan 12, 2016 |