Date Initiated by Firm |
July 06, 2007 |
Date Posted |
July 12, 2007 |
Recall Status1 |
Terminated 3 on February 01, 2013 |
Recall Number |
Z-0990-2007 |
Recall Event ID |
38339 |
510(K)Number |
K024012
|
Product Classification |
fluoroscopic x-ray - Product Code JAA
|
Product |
GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. |
Code Information |
Serial numbers: 8S-2329, 8S-3288-H, 8S-7232-MH, 89-3562. |
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 |
The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by certified letter on 07/06/2007. They were told that a service rep would contact them to provide a label and an addendum to their operator's manual. A permanent software solution is under development and will be provided when it becomes available. |
Quantity in Commerce |
4 units |
Distribution |
Worldwide, including USA, France, Singapore, Sweden, and Switzerland. |
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
|