Date Initiated by Firm |
December 13, 2004 |
Date Posted |
April 08, 2005 |
Recall Status1 |
Terminated 3 on July 08, 2011 |
Recall Number |
Z-0692-5 |
Recall Event ID |
30758 |
510(K)Number |
K022069
|
Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
|
Product |
FluroTrak 9800 Plus Navigation and Visualization System |
Code Information |
The particular accessories (''Sensors'') involved are: Short Range Transmitter (P/N 1004587 or 1002008); Snap Receiver Cable (P/N 1004069 or 1001989); Extended Range Transmitter (P/N 1004070 or 1003991); and T-Handle Spine Tool Receiver (P/N 1004072). |
Recalling Firm/ Manufacturer |
OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact |
GE Healthcare Customer Service 800-874-7378
|
Manufacturer Reason for Recall |
Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
|
FDA Determined Cause 2 |
Other |
Action |
Customers were notified by letter on 12/13/04. |
Quantity in Commerce |
42 units |
Distribution |
Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada. |
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 = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS
|