Date Initiated by Firm | September 07, 2004 |
Create Date | June 25, 2015 |
Recall Status1 |
Terminated 3 on February 10, 2012 |
Recall Number | Z-0494-05 |
Recall Event ID |
31217 |
Product Classification |
Gauging - Product Code rad
|
Product | X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D |
Code Information |
All Serial numbers in domestic distribution. |
Recalling Firm/ Manufacturer |
Toshiba American Med Sys Inc 2441 Michelle Dr Tustin CA 92781
|
For Additional Information Contact | Paul Biggins 714-730-5000 |
Manufacturer Reason for Recall | Non-compliance with Radiation Standards. Incorrect display of the radiographic time, due to software anomaly. |
FDA Determined Cause 2 | Other |
Action | Firm sent recall letters to customers and will be following up with field corrections which will be made on-site by the firm's own employees. |
Quantity in Commerce | 494 |
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.
|