Date Initiated by Firm |
August 16, 2006 |
Date Posted |
September 30, 2006 |
Recall Status1 |
Terminated 3 on July 27, 2011 |
Recall Number |
Z-1301-06 |
Recall Event ID |
36099 |
510(K)Number |
K041931
|
Product Classification |
X-ray system - Product Code JAA
|
Product |
GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact |
801-328-9300
|
Manufacturer Reason for Recall |
X-ray systems could provide output which exceeds the 20 R/minute limit.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by certified letter on 08/14-15/2006. |
Quantity in Commerce |
202 units (US), 26 units (Foreign) |
Distribution |
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 = JAA and Original Applicant = GE OEC MEDICAL SYSTEMS, INC.
|