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Terminated

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

FDA Recall Z-0293-2008 · Posted 2007-11-27

Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2007-10-01
Date Terminated2012-04-05
Product Quantity23

Reason for Recall

System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

Firm 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 Regulatory Affairs Department.

Root Cause

Software design

Distribution Pattern

Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052884MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTORToshiba America Medical Systems, In.C · 2005-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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