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
- Company
- Toshiba American Med Sys Inc
- Recall Initiated
- October 1, 2007
- Posted
- November 27, 2007
- Terminated
- April 5, 2012
- Recall Number
- Z-0293-2008
- Quantity
- 23
- Firm Location
- Tustin, CA
Reason for Recall
System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
Distribution
Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV
Lot / Code Info
Serial numbers: B5522165, W1C0562187, W1C0572197, W1C0572202, W1C0622275, W1C0622270, A3632065, A3622066, W1C0456192, W1C0632284, W1D0722373, W1D0742386, B5512160, W1C0592213, W1C0592215, A4562099, W1C05Z2254, B4582113, W1C0642289, W1D0697015, W1C0552182, W1C05X2224, W1D0742387
Root Cause
Software design
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.