Feb

2008

Cl II GE Medical Systems Information Tech

Company: General Electric Medical Systems Information Technology
Date of Enforcement Report 2/13/2008
Class:ll

PRODUCT
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). (System hardware consists of a processing unit and a monitor), Recall # Z-0280-2008

REASON
Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue.

RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on March 13, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6,217 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II GE Medical Systems Information Tech

Amy Sellers

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