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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Toshiba American Med Sys Inc is recalling Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiogr due to System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026