|
Class 2 Device Recall Optima CT 540 |
|
Date Initiated by Firm |
May 24, 2018 |
Create Date |
July 31, 2018 |
Recall Status1 |
Terminated 3 on February 08, 2019 |
Recall Number |
Z-2586-2018 |
Recall Event ID |
80484 |
510(K)Number |
K082816
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
Optima CT 540 |
Code Information |
Serial number 500925HM3, System ID Number 615320OPT |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact |
800-437-1171
|
Manufacturer Reason for Recall |
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
|
FDA Determined Cause 2 |
Component change control |
Action |
GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative. |
Quantity in Commerce |
42 units total |
Distribution |
Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA. |
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 = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
|
|
|
|