Date Initiated by Firm |
January 24, 2007 |
Date Posted |
June 06, 2007 |
Recall Status1 |
Terminated 3 on December 10, 2011 |
Recall Number |
Z-0891-2007 |
Recall Event ID |
37309 |
510(K)Number |
K032370
|
Product Classification |
Clinical Information Center - Product Code DSI
|
Product |
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. , GE Medical Systems Information Technologies, Inc., 8200 W. Tower Ave. Milwaukee, Wisconsin USA. (System hardware consists of a processing unit and a monitor) |
Code Information |
All serial numbers of Software Version 4.1 |
Recalling Firm/ Manufacturer |
General Electric Medical Systems Information Technology 8200 W Tower Ave Milwaukee WI 53223-3219
|
For Additional Information Contact |
Aimee Klussendorf 800-558-5120 Ext. 2496
|
Manufacturer Reason for Recall |
Alarm and Reboot problems: Two separate issues could occur with the CIC Pro system when used with Telemetry. Each issue occurs in software version v4.1 only; A) the system may experience a loss of audible alarms when operating system memory resources reach 170MB and/or B) the system may intentionally or unexpectedly reboot .
|
FDA Determined Cause 2 |
Other |
Action |
GE Healthcare sent a certified letter titled "Urgent Medical Device Correction" to customers on 3/13/07 that explained the short and long term solutions and that the company would be providing a software update that will rectify the issue specific to CIC Pro v4.1 software. |
Quantity in Commerce |
5,190 Units |
Distribution |
Nationwide |
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 = DSI and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
|