GE Healthcare…

Date posted by the FDA

April 6, 2009

Status

Terminated

Filed by

GE Healthcare

Product

GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05, Datex-Ohmeda Inc., PO Box 7550 Madison, WI 53707-7550, USA, GE Healthcare Finland Oy, Helsinki, Finland PO Box 900. FI-00031 GE. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only.

Reason

GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT> and PVC(1) alarms when used with ApexPro and VT>2 and PVC

Distribution pattern

Worldwide Distribution, USA (and PR) including states of AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY,LA, ME, MI, MN, MS, MO, NH, NJ, NY, NC, OH, PA, SC, TX, VT, VA, WA, and WI and countries of AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BOLIVIA, BRASIL, BULGARIA, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GAYANA, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LIBYAN ARAB JAMAHIRIYA, MACEDONIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NORWAY, PAKISTAN, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SLOVEN IA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, SYRIA ARAB REPUBLIC, THAILAND, TUNAS IA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA and YEMEN.

Quantity

2,146

Codes and lots

Serial Numbers: CZC6261MWB CZC6261MWY CZC5492LK6 CZC61030GL CZC64511LX CZC6482WKP CZC721500G CZC721500H CZC721500J CZC7290DYK CZC7290DYL CZC7290DYT CZC7290DYY 6203582 CZC5521M47 CZC5521M50 CZC7080QKD CZC73312RF CZC73312RP CZC6261MWF CZC7363P37 CZC72414B7 CZC72414BI CZC7250WN8 CZC6103069 CZC6130L3D CZC724149X CZC7272RM7 5225446 6022568 6043180 6065613 6131586 6131596 6203667 6228511 6279463 6307436 CZC5280BRX CZC528244P CZC528244X CZC53003BL CZC5391VF0 CZC5391VG3 CZC5391VGR CZC5472F7W CZC5492LKH CZC5492LKK CZC5510Y67 CZC603076F CZC603076M CZC603076T CZC603076Y CZC61544VJ CZC6181MTL CZC6322Q7G CZC6322Q7W CZC6322Q80 CZC6322Q8C CZC6394DFQ CZC6394DH3 CZC6394DH4 CZC6482WKK CZC6482WKS CZC7414GM8 FRB4210XPW FRB4210XPZ FRB4210XQD FRB4210XQF FRB4210XQG FRB4210XQV FRB4210XQY FRB4210XRD FRB4210XRP FRB4210XSS FRB4210XSX FRB4250QG9 FRB4250QGG FRB4250QGL FRB4250SM7 FRB4250SZR FRB4250T0N FRB4250T0V FRB426012N FRB426013F FRB426014Q 5205328 5170741 5126787 5170740 5170743 6030463 CZC5391VFK CZC5521M48 CZC6228603 CZC64255CB CZC6482WJV CZC7080QJL CZC7080QJZ CZC7364RTP FRB4250QG3 6022570 CZC5492LL9 CZC601030GK 5205326 5205327 5175466 5222754 CZC6394DGP CZC6394DGY CZC7132V7F CZC61030GP CZC6130L35 CZC61544V5 CZC5462BV7 CZC5492LJP CZC5492LKR CZC5492LKX CZC5510Y5Y CZC5521M45 CZC5521M49 CZC5521M4B CZC5521M4C CZC5521M4Y 999999.01 999999.02 999999.03 999999.04 CZC528244V CZC53003BC CZC53003BH CZC53003BJ CZC5521M40 CZC5521M4R CZC5521M4V CZC5521M4X CZC5492LL2 CZC52303S6 CZC52303S8 CZC6181MT7 CZC6261MWS CZC62803TD CZC62803TJ CZC62803TW CZC63128WB CZC63128WN CZC63128WR CZC63128X2 CZC63128X6 CZC6322Q82 CZC6322Q8B CZC6391G9V CZC6394DG0 CZC6394DG1 CZC64006JW CZC64006JZ CZC64006KD CZC64006KX CZC64006KZ CZC64006L2 CZC642558V CZC642558W CZC642559C CZC642559K CZC64255B0 CZC64255B3 CZC64255B5 CZC64255B7 CZC64255BF CZC64255BH CZC64255BM CZC73312RG CZC73312RH CZC73312RL CZC73312S1 CZC7363P2W CZC7363P34 CZC7363P38 CZC7363P3C CZC7363P3G CZC7363P3J CZC7363P3K CZC7364RT6 CZC5391VF3 CZC61030GM CZC6130L2X 5213740 5170753 5182721 CZC5391VGG 5156076 5156077 5156078 5156284 5165853 5205776 5205777 5213727 5213728 5213729 5213730 5213731 5213732 5213733 5213734 FRB4250SZY CZC7414GGD CZC7414GJH CZC6482WKL CZC72414B9 CZC5492LKS CZC63128X5 CZC6482WKM FRB4210XSV FRB4250SM8 CZC6130L3F CZC5510Y64 CZC7250WNJ 6004804 CZC5492LL2 CZC7215010 CZC6394DGV CZC6261MW4 CZC6261MWZ CZC64006KB CZC5240Q16 CZC5240Q18 CZC5240Q1J CZC61030G8 CZC5492LJQ CZC7132V6M CZC7132V83 CZC7290DZ1 CZC5391VF4 CZC6394DFG CZC7364RV6 FRB4210XQ9 FRB4210XQZ FRB4260139 CZC61030GC 6161335 6161447 CZC6261MWT CZC63128WT CZC5510Y6G C2C528245B CZC528245B CZC5492LLM CZC6261MW5 6299938 CZC721500D CZC7272RM2 CZC642559Z CZC5240Q1G CZC6261MWM CZC6322Q88 CZC7272RM6 CZC63128WC CZC5510Y6G CZC5492LK5 CZC5492LLD CZC5492LLH CZC5510Y60 CZC5510Y63 CZC5510Y6B CZC5510Y6J CZC5510Y6M CZC5510Y6N CZC61030GH CZC61030H0 CZC7132V7D CZC7212G4K CZC7212G52 CZC5391VGL CZC5391VDQ CZC6482WKB CZC6482WKY CZC7364RTL CZC7363P2Z CZC7363P3M CZC64006JT CZC64006JY CZC6130L2N…

Recall started

Jan. 26, 2009

Device type

System, Network And Communication, Physiological Monitors

Root cause (FDA)

Software design

What the company told customers

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated January 26, 2009 addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the safety issue, affected product details, safety instructions, product correction and contact information. Direct questions to GE Healthcare at 1-800-558-7044, Option 2 and ask for Technical Support or contact your local GE Healthcare Distributor.

Recall number

Z-1039-2009

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

Source: FDA · Medical device enforcement report, recall number Z-1039-2009. The agency record governs; check it and the company before acting.