ClearanceBrief
Recall Z-1558-2009 ยท MSX System, Network And Communication, Physiological Monitors

GE Medical Systems, LLC

Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for us

DateSep 4, 2009 (initiated May 8, 2009)
StatusTerminated
ReasonGE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an
Root causeSoftware design
ActionAn "Urgent Medical Device Correction" letter was issued to consignees on or about April 9, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. A representative from GE Healthcare will contact customers to schedule implementation of the correction when it is available for installation at the customer's facility. Direct questions regarding this notice to GE Healthcare Technical Support or
Quantity2,638
DistributionWorldwide Distribution -- US (including DC and states of AL, AK, AZ, AR, CA, CO, FL, IL, IN, IA, KS, KY, LA, ME, MD, MI,MN, MO,MT, NE, NH, NJ, NY, NC, OH, OK OR, PA, SC, TX, UT,VT, VA, WA, WV and WI) and countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, CYPRUS, DENMARK, ESTONIA, FRAN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K070421DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
GE Healthcare, Mar 13, 2007