Date Initiated by Firm | March 24, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on July 24, 2006 |
Recall Number | Z-0900-04 |
Recall Event ID |
28747 |
510(K)Number | K890348 |
Product Classification |
System, X-Ray, Angiographic - Product Code IZI
|
Product | Advantx 1 SC Model 36006617 Angiographic X-ray System |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
General Electric Med Systems 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | Larry A. Kroger 262-544-3894 |
Manufacturer Reason for Recall | Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox. |
FDA Determined Cause 2 | Other |
Action | Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals. |
Distribution | The units were distributed nationwide in the United States and worldwide. |
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 = IZI
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