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Terminated

DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral (including iCentral Client) transfers information between networked Datex-Ohmeda devices in the Monitor Network as well as between Monitor Network and networked devices in GE Unity NetworkTM. It also allows information transfer between several iCentrals. Within one Monitor Network it allows a networked device to display, store, print and otherwise process information received from other networked devices. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Monitor Network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda Network, between the Datex-Ohmeda Network and devices in GE Unity Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS). The iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The iCentral Client can be used for remote monitor management, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is for use by qualified personnel only.

FDA Recall Z-2211-2010 · Posted 2010-08-12

Recalling FirmGe Healthcare, Llc
Recall StatusTerminated
Product CodeMSX
Date Initiated2010-06-25
Date Terminated2012-08-14
Product Quantity2962

Reason for Recall

The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing monitoring loss at the central monitoring station. Monitoring loss may result in prolonged delay of treatment of potentially lethal arrhythmia.

Firm Action

GE Healthcare sent a "Urgent Medical Device Correction letter" dated 6/18/10 on 6/25/10 to consignees. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The letter instructs consignees to follow specific detailed instructions for safe use of the device pending provision of a software upgrade by the firm. Consignees will be contacted by a GE Healthcare representative to schedule the software upgrade.

Root Cause

Software design

Distribution Pattern

AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, NE, NH, NH, NY, NC, ND, OH, OK PA, RI, SC, TN, TX VT, VA, WA, WI. ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA , KUWAIT, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND,NICARAGUA, NIGERIA, NORWAY, PHILIPPINES, POLAND, PORTUGAL QATAR, RUSSIAN FEDERATION SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN THAILAND TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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