Date Initiated by Firm | March 12, 2009 |
Date Posted | September 25, 2009 |
Recall Status1 |
Terminated 3 on December 10, 2011 |
Recall Number | Z-1258-2009 |
Recall Event ID |
51879 |
Product Classification |
Computed Tomography X-Ray System - Product Code JAK
|
Product | GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. |
Code Information |
All tables and serial numbers associated with Model Number 2271242. |
Recalling Firm/ Manufacturer |
GE Medical Systems, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
|
For Additional Information Contact | 262-544-3894 |
Manufacturer Reason for Recall | Failure to provide the certification label required by 21 CFR 1010.2. |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems. |
Quantity in Commerce | 1179 total of all units |
Distribution | Nationwide 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.
|