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
|
|
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 = IZI and Original Applicant = GENERAL ELECTRIC CO.
|