S/5 iCentral…

Date posted by the FDA

June 24, 2008

Status

Terminated

Filed by

GE Healthcare

Product

S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, GE Healthcare, Wauwatosa, WI 53226.

Reason

Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.

Distribution pattern

Worldwide Distribution including USA states of AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, PA, SC, TN, TX, VA, VT, WA and WI; and countries of Algeria, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Guans, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen.

Quantity

2146

Codes and lots

CZC7244NXM CZC5510Y6G CZC5510Y6G CZC61030GC CZC5492LL2 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 5156075 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 5205776 5205777 5213714 5213715 5213716 5213717 5213718 5213719 5213720 5213721 5213722 5213723 5213724 5213725 5213727 5213728 5213729 5213730 5213731 5213732 5213733 5213734 5213741 6004804 6161335 6161447 6186167 6299938 6315252 C2C528245B CZC5240Q16 CZC5240Q18 CZC5240Q1G CZC5240Q1J CZC5240Q1L CZC5240Q1Q CZC5280BS7 CZC5280BSD CZC528244Y CZC528245B CZC53003B3 CZC53003B8 CZC53003B9 CZC53003BQ CZC53003BR CZC53003BX CZC5391VDQ CZC5391VF4 CZC5391VFJ CZC5391VFS CZC5391VG5 CZC5391VGL CZC5472F8J CZC5492LJQ CZC5492LK5 CZC5492LKS CZC5492LLD CZC5492LLH CZC5492LLM CZC5510Y60 CZC5510Y63 CZC5510Y64 CZC5510Y6B CZC5510Y6J CZC5510Y6M CZC5510Y6N CZC61030G8 CZC61030GH CZC61030H0 CZC6130L2N CZC6130L2P CZC6130L2S CZC6130L30 CZC6130L3B CZC6130L3F CZC6181MSZ CZC6181MT0 CZC6181MT1 CZC6181MT8 CZC6261MW4 CZC6261MW5 CZC6261MWM CZC6261MWT CZC6261MWZ CZC62803TK CZC62803TR CZC6291WTP CZC6291WTR CZC63128WC CZC63128WT CZC63128X5 CZC6322Q7L CZC6322Q85 CZC6322Q88 CZC6394DFG CZC6394DGV CZC64006JT CZC64006JY CZC64006K3 CZC64006KB CZC642559H CZC642559M CZC642559Z CZC64255BK CZC64255BX CZC64511L8 CZC64511LK CZC6482WKB CZC6482WKL CZC6482WKM CZC6482WKT CZC6482WKY CZC7132V6M CZC7132V6P CZC7132V6V CZC7132V76 CZC7132V79 CZC7132V7D CZC7132V7Z CZC7132V80 CZC7132V83 CZC7212G4K CZC7212G51 CZC7212G52 CZC7215009 CZC721500C CZC721500D CZC721500M CZC721500R CZC721500T CZC7215010 CZC72414B9 CZC7244NXG CZC7244NXJ CZC7250WNJ CZC7272RLH CZC7272RLS CZC7272RM2 CZC7272RM6 CZC7290DYF CZC7290DZ1 CZC73312RZ CZC7363P2Z CZC7363P3M CZC7364RTL CZC7364RV2 CZC7364RV6 CZC7414GGD CZC7414GJH FRB4210XQ9 FRB4210XQZ FRB4210XSV FRB4250QGW FRB4250SM6 FRB4250SM8 FRB4250SZY FRB4250T0D FRB4250T0H FRB4250T0Q FRB4250T10 FRB4250T11 FRB4260139 CZC5492LLJ CZC7244NXQ CZC5391VF7 5100635 5100637 5100640 5100652 5115311 5126769 5126770 5140808 5148400 5170751 5170752 5199050 5205317 5213739 5225432 5225433 6120270 CZC5240Q12 CZC5240Q15 CZC5240Q19 CZC5240Q1B CZC5460C82 CZC5462HW6 CZC6030779 CZC6130L37 CZC6181MTD CZC6181MTG CZC6181MTS CZC6181MTT CZC6181MTY CZC62803T3 CZC62803TG CZC62803TX CZC6322Q86 CZC6394DG6 CZC64255C5 CZC7080QKF CZC7132V7S CZC7132V7Y CZC7212G4Y CZC7212G53 CZC721500Y FRB4250T0F FRB426012Z CZC528244Z CZC603077D CZC61030GC 5077175 5126785 5132684 5156286 5156287 5156288 5156289 5156290 5165839 5165840 5165841 5165842 5165843 5165844 5165845 5165846 5165847 5165848 5165849 5165850 5165851 5165852 5175459 5175467 5175468 5182673 5182692 5182696 5199062 5205307 5205316 5205321 5205323…

Recall started

Dec. 13, 2007

Device type

System, Network And Communication, Physiological Monitors

Root cause (FDA)

Device Design

What the company told customers

Consignees were notified via a Medical Device Correction letter on 12/13/07. The letter explained the circumstances in which the "connection to monitor loss" alarm would not display, if a monitor was disconnected. The letter also included an attachment entitled "How to ensure a 'Connection to monitor lost' alarm on iCentral." For additional information, contact 1-800-558-7044.

Recall number

Z-1161-2008

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

Source: FDA · Medical device enforcement report, recall number Z-1161-2008. The agency record governs; check it and the company before acting.