Date Initiated by Firm | May 25, 2005 |
Date Posted | July 13, 2005 |
Recall Status1 |
Terminated 3 on April 05, 2012 |
Recall Number | Z-0986-05 |
Recall Event ID |
32570 |
510(K)Number | K002531 K961092 K990620 K993803 |
Product Classification |
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
|
Product | Magnetic Resonance Imaging Systems;
Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE. |
Code Information |
All. |
Recalling Firm/ Manufacturer |
Toshiba American Med Sys Inc 2441 Michelle Dr Tustin CA 92781
|
For Additional Information Contact | Michaela Mahl 714-730-5000 |
Manufacturer Reason for Recall | Patient information A is displayed with images for patient B. |
FDA Determined Cause 2 | Other |
Action | Firm will have technicians correct each unit by visit. Instructions to them have issued. |
Quantity in Commerce | 102 |
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 = LNH 510(K)s with Product Code = LNH
|