# K052972: Datex-Ohmeda Network and Icentral '05, Sales Revision 4.3

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Dec 29, 2005 after 66 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000647 (2000). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042771: GE Datex-Ohmeda S/5 Network and Icentral '03, Sales Revision 3.3, Datex-Ohmeda (2004) Summary page 1.

## Most influential descendants
- K071097: Navigator Applications Suite (2007), 4 descendants of its own
- K081941: Navigator Applications Suite (2008), 3 descendants of its own
- K083098: Navigator Applications Suite (2009), 2 descendants of its own
- K102389: Navigator Applications Suite (2011), 1 descendant of its own
- K103035: Smartpilot View Model MK04500 (2012), 0 descendants of its own

## Recalls of this device
- Jun 25, 2010 · Not classified · Z-2211-2010: The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing monitoring loss at the central monitoring station. Monitoring loss may result in prolonged delay of 
- Jan 26, 2009 · Not classified · Z-1039-2009: GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8
- Dec 13, 2007 · Not classified · Z-1161-2008: Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.

## Indications for use
The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity Network™. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.

Source page: https://510kreport.com/device/K052972
Methodology: https://510kreport.com/methodology