Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for In
FDA device recall Z-0005-2009 · posted 2009-09-28 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.
- Action taken
- Toshiba issued a letter entitled Important Electronic Product Radiation Warning, September 30, 2008, explaining the issue. The customers were requested to reply to the letter via fax-back form, and a Toshiba service representative would install the corrective action.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 129
- Distribution
- Nationwide
- Date initiated
- 2008-09-29
- Date posted
- 2009-09-28
- Date terminated
- 2012-10-04
- 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-8000F (INFINIX CSI AND INFINIX DPI) (K081624) | Toshiba America Medical Systems, In.C | 2008-06-23 |