Jun

2007

GE Healthcare CIC Pro Clinical InformationClass II

Company:General Electric Medical Systems Information Technology
Date of Enforcement Report:6/20/2007
Class:ll

PRODUCT
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (System hardware consists of a processing unit and a monitor), Patient Monitor, Recall # Z-0891-2007

REASON
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.

CODE
All serial numbers of Software Version 4.1

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
5,190 units

DISTRIBUTION
Nationwide

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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GE Healthcare CIC Pro Clinical InformationClass II

Amy Sellers

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