Date Initiated by Firm |
September 29, 2008 |
Date Posted |
September 28, 2009 |
Recall Status1 |
Terminated 3 on October 04, 2012 |
Recall Number |
Z-0005-2009 |
Recall Event ID |
53451 |
510(K)Number |
K081624
|
Product Classification |
Controller for interventional angiography systems. - Product Code MQB
|
Product |
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. |
Code Information |
Software version 3.40 or higher |
Recalling Firm/ Manufacturer |
Toshiba American Medical Systems Inc 2441 Michelle Dr P.O. Box 2068 Tustin CA 92781-2068
|
For Additional Information Contact |
714-730-5000
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
Software design |
Action |
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. |
Quantity in Commerce |
129 |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = MQB and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
|