Date Initiated by Firm |
January 31, 2011 |
Date Posted |
February 17, 2012 |
Recall Status1 |
Terminated 3 on September 06, 2012 |
Recall Number |
Z-0833-2012 |
Recall Event ID |
57842 |
|
|
Product Classification |
Cabinet x-ray, industrial - Product Code RCE
|
Product |
GE eXplore Locus Micro CT cabinet x-ray system model RS9-80.
CT Scanner for laboratory mice or other research. |
Code Information |
Part Number 5134163. |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact |
262-513-4122
|
Manufacturer Reason for Recall |
Product fails to comply with the federal performance standard for cabinet x-ray systems (Title 21 CFR 1020.40(c)(1)(i)). Specifically, the x-ray emission limit of 0.5 milliroentgen in one hour could be exceed. Highest emission measured was 3 mR/hr.
|
FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
Action |
GE Healthcare will notify purchasers of the problem, the affected product, instructions for users, and specify the maximum emission rate measured. GE Healthcare will bring defective systems into compliance free of charge. This will be done via Field Modification Instructions IFMI) 11101 which is scheduled for deployment on March 1, 2011 with an estimated completion date of July 1, 2011. |
Quantity in Commerce |
21 |
Distribution |
Worldwide Distribution |
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.
|