Recall Z-1039-2009 ยท MSX System, Network And Communication, Physiological Monitors
GE Healthcare
GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finland PO Box 900. FI-00031 GE. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hard
| Date | Apr 6, 2009 (initiated Jan 26, 2009) |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated January 26, 2009 addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the safety issue, affected product details, safety instructions, product correction and contact information. Direct questions to GE Healthcare at 1-800-558-7044, Option 2 and ask for Technical Support or contact your local GE Healthcare Distributor. |
| Quantity | 2,146 |
| Distribution | Worldwide Distribution, USA (and PR) including states of AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY,LA, ME, MI, MN, MS, MO, NH, NJ, NY, NC, OH, PA, SC, TX, VT, VA, WA, and WI and countries of AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052972 | DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE Healthcare, Dec 29, 2005 |