Terminated

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.

FDA Recall Z-1558-2009 · Posted 2009-09-04

Recalling FirmGE Medical Systems, LLC

Recall StatusTerminated

Product CodeMSX

Date Initiated2009-05-08

Date Terminated2012-02-04

Product Quantity2,638

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

Firm Action

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.

Root Cause

Software design

Distribution Pattern

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 JAMAHIRIYA, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, PORTUGAL SAUDI ARABIA, SERBIA, SOUTH AFRICA, SWEDEN SWITZERLAND, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070421DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02GE Healthcare · 2007-03-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.