Recall Z-0293-2008 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Toshiba American Med Sys Inc
Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780
| Date | Nov 27, 2007 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error. |
| Root cause | Software design |
| Action | 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 Regula |
| Quantity | 23 |
| Distribution | Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052884 | MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR Toshiba America Medical Systems, In.C, Oct 26, 2005 |