Company:General Electric Medical Systems Information Technology
Date of Enforcement Report 5/13/2009
Class:ll
PRODUCT
GE Healthcare CIC Pro” Software Versions 5.0.3, 5.0.6 , 5.0.7, 5.0.8 and 4.1. The CIC Pro” Clinical Information Center Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. The CIC Pro Central Station is intended to collect information from a network and display this data. This data included physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from GE Healthcare Information Technologies monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information central station. Beat to beat patient information for all parameters and waveforms from he bedsides and telemetry systems can be displayed. The CIC Pro Clinical Information Center central station supports the ability to access information from GE Medical Systems Information Technologies products in web browser format. Additionally, the CICC Pro clinical Information central station supports the ability to access patient information collected from the unity network and stored on a network server. Recall # Z-1232-2009
REASON
Potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro” software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use of this device in conjunction with this device correction
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems Information Technology, Wauwatosa, WI, by letter dated February 27, 2009.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12,737 units
DISTRIBUTION
Nationwide and Internationally
