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U.S. Department of Health and Human Services

Class 2 Device Recall CIC Pro System

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 Class 2 Device Recall CIC Pro Systemsee related information
Date Initiated by FirmJanuary 24, 2007
Date PostedJune 06, 2007
Recall Status1 Terminated 3 on December 10, 2011
Recall NumberZ-0891-2007
Recall Event ID 37309
510(K)NumberK032370 
Product Classification Clinical Information Center - Product Code DSI
ProductGE 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 ContactAimee 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
ActionGE 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 Commerce5,190 Units
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSI
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