Toshiba American Medical Systems Inc Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Brand
Toshiba American Medical Systems Inc
Lot Codes / Batch Numbers
Software version 3.40 or higher
Products Sold
Software version 3.40 or higher
Toshiba American Medical Systems Inc is recalling Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher softwar due to 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 Hi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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