Date Initiated by Firm |
December 27, 2016 |
Date Posted |
January 20, 2017 |
Recall Status1 |
Terminated 3 on July 12, 2018 |
Recall Number |
Z-1059-2017 |
Recall Event ID |
76074 |
510(K)Number |
K132027 K111551
|
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product |
OEC 9800. MDL Numbers: D222250, D141598 |
Code Information |
Manufactured from Feb 1998 to present |
Recalling Firm/ Manufacturer |
GE OEC Medical Systems, Inc 384 N Wright Brothers Dr Salt Lake City UT 84116-2862
|
For Additional Information Contact |
Deena Pease 801-536-4952
|
Manufacturer Reason for Recall |
GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement frequencies.
|
FDA Determined Cause 2 |
Packaging change control |
Action |
The customer communication is expected to begin distribution in January 2017. Consignees will be notified of the availability of the Operator Manual supplement via a letter. No product is being returned. |
Quantity in Commerce |
26,256 total |
Distribution |
Worldwide including govt/VA/military and foreign consignees. |
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 = OWB and Original Applicant = GE OEC MEDICAL SYSTEMS, INC
|