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
| Record | Firm | Date |
|---|---|---|
| CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION (K032370) | Ge Medical Systems Information Technologies | 2003-08-13 |