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

FDA device recall Z-0030-05 · posted 2004-10-21 · Terminated

Recall details

Recalling firm
General Electric Medical Systems Information Technology
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.
Root cause
Other
Status
Terminated
Product code
DSI
Quantity affected
11,778
Distribution
Distributed nationwide throughout the United States and worldwide.
Date initiated
2004-10-11
Date posted
2004-10-21
Date terminated
2006-07-22
Location
Milwaukee, WI

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Related 510(k) clearances

RecordFirmDate
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K032370)Ge Medical Systems Information Technologies2003-08-13