Recall Z-1558-2009
GE Medical Systems, LLC · initiated May 8, 2009
Product
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 use by qualified medical personnel only.
Codes / lots: Parent Serial Number: 6309715 6309716 6309717 6309718 6309719 6439662 6439663 6373962 6373963 6260564 6341724 6341725 6397037* 6397038* 6399507 6478114 6478115 6478116 6260575 6260576 6260577 6260578 6260579 6260580 6260581 6260582 6260583 6260584 6260585 6260586 6260587 6195535 6195539 6195540 6195541 6195542 6195543 6195544 6195545 6195546 6195547 6195548 6195549 6195550 6229242 6238630 6238679 6260591 6260596 6260597 6260598 6260599 6260600 6279857 6279858 6279859 6279928 6279937 6279938 6279939 6279940 6279941 6279942 6306020 6309692 6309693 6309694 6341753 6341754 6341755 6341756 6385971 6388639 6395704 6395705 6395706 6395707 6397073 6428643 6438603 6438622 6438623 6438624 6438625 6438630 6438631 6444995 6451312 6451313 6451314 6465232 6465236 6465237 6468815 6483711 6175623 6175624 6175625 6175626 6175627 6175628 6175629 6175630 6175631 6175632 6175633 6175651 6175652 6175653 6175654 6175655 6175663 6175664 6195528 6195536 6195537 6229265 6229266 6229267 6238701 6260558 6272984 6272990 6272991 6272992 6272993 6272994 6272995 6279848 6279849 6279850 6279851 6279852 6279853 6279854 6279855 6279856 6279867 6279872 6279873 6279881 6279882 6279883 6279884 6279885 6279886…
Reason for recall
GE 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
FDA-determined cause: Software design
Action taken
An "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 your local GE Distributor and refer to FMI 36042.
Details
- Recall number
- Z-1558-2009
- Initiated
- May 8, 2009
- Posted by FDA
- September 4, 2009
- Terminated
- February 4, 2012
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Quantity
- 2,638
- Distribution
- Worldwide 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, FRANCE, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LIBYAN ARAB…
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI