Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Soft
FDA device recall Z-0293-2008 · posted 2007-11-27 · Terminated
Recall details
- Recalling firm
- Toshiba American Med Sys Inc
- Reason for recall
- System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
- Action taken
- Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 23
- Distribution
- Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV
- Date initiated
- 2007-10-01
- Date posted
- 2007-11-27
- Date terminated
- 2012-04-05
- 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 |
|---|---|---|
| MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR (K052884) | Toshiba America Medical Systems, In.C | 2005-10-26 |