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Class 2 Device Recall Toshiba America Medical Systems, Inc., Digital Radiography System Model DFP8000D |
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| Date Initiated by Firm |
November 15, 2005 |
| Date Posted |
February 23, 2006 |
| Recall Status1 |
Terminated 3 on July 12, 2007 |
| Recall Number |
Z-0532-06 |
| Recall Event ID |
34102 |
| 510(K)Number |
K013608
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| Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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| Product |
Toshiba Digital Radiography System Model DFP8000D |
| Code Information |
Serial #s W1C0552175, W1C0552181, W1C0562189 |
Recalling Firm/
Manufacturer |
Toshiba American Med Sys Inc
2441 Michelle Dr
Tustin CA 92781
|
| For Additional Information Contact |
Paul Biggins
714-730-5000
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Manufacturer Reason
for Recall |
In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.
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FDA Determined
Cause 2 |
Other |
| Action |
An Advisory Letter will be sent to customers via certified mail. Corrected software will be provided at no charge. Customers can contact their local Toshiba Service person to schedule the software update. |
| Quantity in Commerce |
3 |
| Distribution |
CO, MI, & TX |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
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