INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
FDA device recall Z-0752-2016 · posted 2016-02-09 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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".
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 4
- Distribution
- US Nationwide Distribution to OH and NY
- Date initiated
- 2015-08-14
- Date posted
- 2016-02-09
- Date terminated
- 2016-05-18
- Location
- Tustin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INFX-8000V, V6.20 (K152696) | Toshibamedical Systems Corporation | 2016-01-12 |
| INFX-8000V with Wireless Footswitch (K143225) | Toshibamedical Systems Corporation | 2015-01-09 |
| INFX-8000V, V5.30 (K133535) | Toshibamedical Systems Corporation | 2014-07-23 |
| INFX-8000V WITH (K120073) | Toshibamedical Systems Corporation | 2012-01-26 |