Datex-Ohmeda Network And Icentral '05…

Date posted by the FDA

Aug. 12, 2010

Status

Terminated

Filed by

Ge Healthcare, Llc

Product

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.

Reason

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.

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.

Quantity

2962

Codes and lots

Parent SN CZC53003BQ CZC53003BR CZC53003BX CZC7414GJD CZC7414GLN CZC5510Y64 CZC721500D CZC7272RM2 CZC7414GFS CZC7520S3Y CZC53003B3 CZC53003B8 CZC53003B9 CZC7520S16 CZC7520S18 CZC6322Q7L CZC64511L8 CZC84095RN FRB4210XQ9 FRB4210XQZ FRB4260139 CZC5240Q1L CZC5472F8J CZC6482WKL CZC73312RN CZC6130L3B CZC6261MW4 CZC6261MWZ CZC5280BS7 CZC94890SW CZC7520RZ0 CZC7520S2X CZC5240Q1G GB8627CX31 CZC642559Z CZC5391VGL 5100648 5100649 5100650 5100651 5100653 5100654 5100655 5115314 5123573 5123574 5123575 5123578 5132670 5132671 5132672 5132673 5132674 5132675 5132676 5132677 5132678 5132679 5132680 5132681 5140814 5148398 5148399 5148404 5148405 5148406 5148407 5148408 5156076 5156077 5156078 5156079 5156080 5156081 5156284 5165853 5165868 5171824 5173135 5178892 5178893 5178894 5178895 5178896 5178898 5178899 5178900 5182706 5182709 5182710 5182711 5182718 5199055 5199063 5199080 5213727 5213728 5213729 5213730 5213731 5213732 5213733 5213734 5213741 6161335 6186167 6299938 CZC7364RTL CZC7414GK1 CZC7520RZH CZC7520S49 CZC931344X CZC931344Z CZC7272RM6 FRB4250SZY CZC6181MT8 CZC64006K3 CZC6322Q85 CZC642559H CZC0044VYY CZC0044VZ5 CZC0044VZ7 CZC0044VZ8 CZC92520VB CZC92520VD CZC92520VL CZC62803TK CZC62803TR CZC7244NXG CZC7244NXJ CZC721500R CZC721500T 5205304 5213704 5213705 5225449 CZC6130L3F CZC7520S3S CZC61030G8 CZC92520TS CZC92520TZ CZC92520V0 CZC92520W0 CZC64255BK 5182691 CZC7520RYL CZC7520RYM CZC7520RYN CZC7520RYP CZC7520RYW CZC7520RYY CZC7520RZ2 CZC7520RZ3 CZC7520RZS CZC7520S0G CZC7520S0Z CZC7520S13 CZC7520S14 CZC7520S2M CZC7520S44 CZC7132V6M CZC7132V83 CZC7215009 CZC721500M CZC0044VYG CZC6261MWT CZC63128WT CZC8304C9W CZC7250WNJ CZC6181MT1 CZC5240Q16 CZC5240Q18 CZC5240Q1J CZC8304C9Z CZC8304CB1 CZC8304CBW CZC8304CC0 CZC63128WC CZC84912DT CZC7215010 CZC61030GC FRB3470CPS CZC7132V79 CZC6394DFG CZC7520RZF CZC8304CBC CZC84095RB CZC84095RH CZC84095S0 CZC84095S2 FRB4210XSV FRB4250SM8 CZC5492LKS CZC63128X5 CZC5391VFJ CZC7520RZM CZC93311FP CZC93311G3 CZC7364RV6 CZC6181MSZ CZC64511LK CZC94890RS CZC94890S3 CZC5510Y6G CZC5510Y6J CZC61030GH CZC61030H0 FRB4250QGW CZC528244Y FRB4250T11 CZC64006JT CZC64006JY CZC94438TD CZC5280BSD CZC5391VG5 FRB4250SM6 CZC7272RLH CZC6130L30 CZC6482WKT CZC6394DGV CZC7272RLS C2C528245B CZC528245B CZC5492LLM CZC6261MW5 CZC84912DR CZC9151RLG CZC92520TW CZC9313455 CZC9387DM7 CZC94438SH CZC7363P2Z CZC7363P3M CZC7414GH8 CZC5391VF4 CZC7414GGD CZC7414GJH GB8717D5DA CZC5391VGC CZC6291WTP CZC6291WTR CZC6103GG CZC64006KB CZC721500C CZC5492LLK CZC603076D CZC0044VZB CZC0016T08 CZC0016T09 CZC0044VY8 CZC0044VYL CZC0044VZ1 CZC642559M CZC7414GMB CZC7290DZ1 CZC7132V7D CZC84857GK CZC7364RV2 CZC8304C9Q CZC7290DYF CZC7520S3X CZC94890S6 CZC6181MT0 CZC6261MWM CZC7520S4F CZC84095QX CZC5510Y6M CZC5492LK5 CZC5492LLD CZC5492LLH CZC5510Y60 CZC5510Y63 CZC5510Y6B CZC5510Y6N CZC7212G4K CZC7212G52 CZC83797HC CZC84857GN CZC7520S02 CZC7520S0C CZC64255BX CZC7212G51 FRB4250T0Q CZC6482WKM CZC72414B9 CZC73312RZ CZC6130L2N CZC6130L2P CZC6130L2S CZC84912F2 CZC83053JZ CZC7244NXM…

Recall started

June 25, 2010

Device type

System, Network And Communication, Physiological Monitors

Root cause (FDA)

Software design

What the company told customers

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.

Recall number

Z-2211-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2211-2010. The agency record governs; check it and the company before acting.