Company:GE Healthcare.
Date of Enforcement Report 4/8/2009
Class:ll
PRODUCT
GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only, Recall # Z-1039-2009
REASON
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, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT> and PVC(1) alarms when used with ApexPro and VT>2 and PVC (1) when used when used with Solar, DASH or Eagle (Cardiac Package software). The concern is that this issue may lead to delay in treatment.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa , WI , by letter dated January 26, 2009.
Manufacturer: GE Healthcare Finland Oy, Helsinki , Finland . Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,146 units
DISTRIBUTION
Nationwide and Internationally
