Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0030-05

GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6

GE Medical Systems Information Technologies, Inc. / initiated 2004-10-11 / Terminated

General Electric Medical Systems Information Technology began a recall of GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6 on . The reason FDA records is "The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0030-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Medical Systems Information Technologies, Inc.
Product
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Product code
DSI Detector And Alarm, Arrhythmia
Reason for recall
The following two conditions may occur with the printing of full disclosure strips and reports, printing of the alarm history events stored on a GE Unity Network Patient Data Server (PDS), and printing of caliper reports in the GE CIC Pro central station monitoring product, 1) a delay or cessation in updating portions of th display screen: or, 2) System reset/restart.
FDA root cause
Other
Quantity in commerce
11,778
Distribution
Distributed nationwide throughout the United States and worldwide.
Product codes and lots
All serial numbers for versions 3.x, 4.0.5, and 4.0.6