Date Initiated by Firm |
February 21, 2017 |
Date Posted |
February 27, 2017 |
Recall Status1 |
Terminated 3 on April 24, 2017 |
Recall Number |
Z-1469-2017 |
Recall Event ID |
76568 |
510(K)Number |
K003837
|
Product Classification |
Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
|
Product |
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems |
Code Information |
OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016. |
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 |
OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
|
FDA Determined Cause 2 |
Process control |
Action |
On February 21, 2017, an Urgent Medical Device Correction letter was sent to one consignee with an affected unit; a field service representative hand delivered the customer communication. |
Quantity in Commerce |
1 |
Distribution |
One consignee in CA. |
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 = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS
|