CARESCAPE Respiratory Modules E-sCO…

Date

Sept. 17, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor -Airway Gas Option N-CAiO modules with B40 Patient Monitor

Reason

GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.

Distribution pattern

US: CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI. OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.

Quantity

748 (307 units US, 441 units OUS)

Codes and lots

Mfg Lot or Serial # System ID SGV14019647HA M1199109 SGV14127799HA M1199109 SGV14138150HA M1198397 SGV14148747HA M1199109 SGV14148788HA M1199049 SGV14150001HA M1199109 SGV14150005HA M1199109 SGV14150007HA M1199109 SGV14150037HA M1199109 SGV14150039HA M1199109 SGV14150041HA M1199109 SGV14150042HA M1199109 SGV14150043HA M1199109 SGV14150044HA M1199109 SGV14150045HA M1199109 SGV14150051HA M1199109 SGV14150060HA M1199109 SGV14150064HA M1199109 SGV14150068HA M1199109 SGV14150071HA M1199109 SGV14150074HA M1199109 SGV14150075HA M1199109 SGV14150079HA M1199109 SGV14150170HA M1199109 SGV14150179HA M1199109 SGV14150180HA M1199109 SGV14150182HA M1199109 SGV14150194HA M1199109 SGV14150195HA M1199109 SGV14150197HA M1199109 SGV14150203HA M1199109 SGV14150204HA M1199109 SGV14150207HA M1199109 SGV14150208HA M1199109 SGV14159469HA M1199109 SGV14159471HA M1199109 SGV14159472HA M1199109 SGV14159484HA M1199109 SGV14159488HA M1199109 SGV14159489HA M1199109 SGV14159490HA M1199109 SGV14159494HA M1199109 SGV14159498HA M1199109 SGV14159499HA M1199109 SGV14159501HA M1199109 SGV14159502HA M1199109 SGV14159504HA M1199109 SGV14159505HA M1199109 SGV14159506HA M1199109 SGV14159507HA M1199109 SGV14159685HA M1199109 SGV14159688HA M1199109 SGV14159689HA M1199109 SGV14159692HA M1199109 SGV14159694HA M1199109 SGV14159695HA M1199109 SGV14159698HA M1199109 SGV14159703HA M1199109 SGV14159707HA M1199109 SGV14159709HA M1199109 SGV14159713HA M1199109 SGV14159716HA M1199109 SGV14159717HA M1199109 SGV14159718HA M1199109 SGV14159722HA M1199109 SGV14159728HA M1199109 SGV14159966HA M1199109 SGV14159971HA M1199109 SGV14159976HA M1199109 SGV14159978HA M1199109 SGV14159979HA M1199109 SGV14159990HA M1199109 SGV14159995HA M1199109 SGV14159999HA M1199109 SGV14160322HA M1199109 SGV14160324HA M1199109 SGV14160325HA M1199109 SGV14160511HA M1199109 SGV14160512HA M1199109 SGV14160513HA M1199109 SGV14160514HA M1199109 SGV14160515HA M1199109 SGV14160519HA M1199109 SGV14160520HA M1199109 SGV14160522HA M1199109 SGV14160524HA M1199109 SGV14160525HA M1199109 SGV14160526HA M1199109 SGV14160529HA M1199109 SGV14160532HA M1199109 SGV14160534HA M1199109 SGV14160539HA M1199109 SGV14160545HA M1199109 SGV14181423HA M1199049 SGV14181424HA M1199049 SGV14181425HA M1199049 SGV14181426HA M1199049 SGV14181427HA M1199049 SGV14181428HA M1199049 SGV14181429HA M1199049 SGV14181430HA M1199049 SGV14181432HA M1199049 SGV14181433HA M1199049 SGV14181434HA M1199049 SGV14181436HA M1199049 SGV14181441HA M1199049 SGV14181442HA M1199049 SGV14181447HA M1199049 SGV14181451HA M1199049 SGV14181452HA M1199049 SGV14181453HA M1199049 SGV14181457HA M1199049 SGV14181458HA M1199049 SGV14181459HA M1199049 SGV14181460HA M1199049 SGV14181461HA M1199049 SGV14181609HA M1199049 SGV14181610HA M1199049 SGV14181611HA M1199049 SGV14181612HA M1199049 SGV14181613HA M1199049 SGV14181614HA M1199049 SGV14181615HA M1199049 SGV14181616HA M1199049 SGV14181618HA M1199049 SGV14181621HA M1199049 SGV14181622HA M1199049 SGV14181624HA M1199049 SGV14181628HA M1199049 SGV14181630HA M1199049 SGV14181631HA M1199049 SGV14181633HA M1199049 SGV14181635HA M1199049 SGV14181641HA M1199049 SGV14181642HA M1199049 SGV14181643HA M1199049 SGV14181648HA M1199049 SGV14181853HA M1199049 SGV14181854HA M1199049 SGV14181856HA M1199049 SGV14181859HA M1199049 SGV14181860HA M1199049 SGV14181997HA M1199109 SGV14181999HA M1199109 SGV14182000HA M1199109 SGV14182001HA M1199109 SGV14182003HA M1199109 SGV14182005HA M1199109 SGV14182007HA M1199109 SGV14182008HA M1199109 SGV14182009HA M1199109 SGV14182010HA M1199109 SGV14182011HA M1199109 SGV14182012HA M1199109 SGV14182015HA M1199109 SGV14192266HA M1198396 SGV14192272HA M1198396 SGV14192612HA M1199049 SGV14192613HA M1199049 SGV14192614HA M1199049 SGV14192616HA M1199049 SGV14192619HA M1199049 SGV14192621HA M1199049 SGV14192622HA M1199049 SGV14192623HA M1199049 SGV14192624HA M1199049 SGV14192625HA M1199049 SGV14192626HA M1199049 SGV14192627HA M1199049 SGV14192628HA M1199049 SGV14192629HA M1199049 SGV14192630HA M1199049 SGV14192631HA M1199049 SGV14192632HA M1199049 SGV14192633HA M1199049 SGV14192634HA M1199049 SGV14192635HA M1199049 SGV14192636HA M1199049 SGV14192637HA M1199049 SGV14192638HA M1199049 SGV14192639HA M1199049 SGV14192640HA M1199049 SGV14192641HA M1199049 SGV14192642HA M1199049 SGV14192643HA M1199049 SGV14192644HA M1199049 SGV14192645HA M1199049 SGV14192646HA M1199049 SGV14192647HA M1199049 SGV14192649HA M1199049 SGV14192650HA M1199049 SGV14192651HA M1199049 SGV14192652HA M1199049 SGV14192653HA M1199049 SGV14192654HA M1199049 SGV14192655HA M1199049 SGV14192656HA M1199049 SGV14192657HA M1199049 SGV14192658HA M1199049 SGV14192659HA M1199049 SGV14192660HA M1199049 SGV14192661HA M1199049 SGV14192723HA M1199109 SGV14192725HA M1199109 SGV14192727HA M1199109 SGV14192729HA M1199109 SGV14192730HA M1199109 SGV14192733HA M1199109 SGV14192735HA M1199109 SGV14192737HA M1199109 SGV14192743HA M1199109 SGV14192744HA M1199109 SGV14192746HA M1199109 SGV14192747HA M1199109 SGV14192750HA M1199109 SGV14192751HA M1199109 SGV14192754HA M1199109 SGV14192755HA M1199109 SGV14192765HA M1199109 SGV14192980HA M1199109 SGV14192983HA M1199109 SGV14192990HA M1199109 SGV14192995HA M1199109 SGV14192998HA M1199109 SGV14203007HA M1199049 SGV14203008HA M1199049 SGV14203009HA M1199049 SGV14203011HA M1199049 SGV14203012HA M1199049 SGV14203013HA M1199049 SGV14203014HA M1199049 SGV14203015HA M1199049 SGV14203016HA M1199049 SGV14203017HA M1199049 SGV14203018HA M1199049 SGV14203019HA M1199049 SGV14203020HA M1199049 SGV14203021HA M1199049 SGV14203022HA M1199049 SGV14203023HA M1199049 SGV14203024HA M1199049 SGV14203025HA M1199049 SGV14203026HA M1199049 SGV14203028HA M1199049 SGV14203030HA M1199049 SGV14203031HA M1199049 SGV14203032HA M1199049 SGV14203033HA M1199049 SGV14203034HA M1199049 SGV14203035HA M1199049 SGV14203036HA M1199049 SGV14203038HA M1199049 SGV14203039HA M1199049 SGV14203040HA M1199049 SGV14203042HA M1199049 SGV14203043HA M1199049 SGV14203044HA M1199049 SGV14203045HA M1199049 SGV14203048HA M1199049 SGV14203049HA M1199049 SGV14203050HA M1199049 SGV14203052HA M1199049 SGV14203053HA M1199049 SGV14203054HA M1199049 SGV14203055HA M1199049 SGV14203056HA M1199049 SGV14203245HA M1199049 SGV14203246HA M1199049 SGV14203247HA M1199049 SGV14203252HA M1199049 SGV14203253HA M1199049 SGV14203257HA M1199049 SGV14203258HA M1199049 SGV14203261HA M1199049 SGV14203264HA M1199049 SGV14203265HA M1199049 SGV14203266HA M1199049 SGV14203267HA M1199049 SGV14203269HA M1199049 SGV14203270HA M1199049 SGV14203271HA M1199049 SGV14203272HA M1199049 SGV14203273HA M1199049 SGV14203274HA M1199049 SGV14203276HA M1199049 SGV14203279HA M1199049 SGV14203283HA M1199049 SGV14203290HA M1199049 SGV14203292HA M1199049 SGV14203395HA M1198397 SGV14203399HA M1198397 SGV14203400HA M1198397 SGV14203401HA M1198397 SGV14203402HA M1198397 SGV14203408HA M1198397 SGV14203409HA M1198397 SGV14203415HA M1198397 SGV14203417HA M1198397 SGV14203418HA M1198397 SGV14224433HA M1199109 SGV14224435HA M1199109 SGV14224441HA M1199109 SGV14224445HA M1199109 SGV14224455HA M1199109 SGV14224457HA M1199109 SGV14224458HA M1199109 SGV14224465HA M1199109 SGV14160351HA M1217240 SGV14160352HA M1217240 SGV14181897HA M1217240 SGV14181898HA M1217240 SGV14192732HA M1184207 SGV14150073HA 2067388-001 SGV14150191HA 2067388-001 SGV14150192HA 2067388-001 SGV14159704HA 2067388-001 SGV14159985HA 2067388-001 SGV14159991HA 2067388-001 SGV14170899HA 2070619-001 SGV14170905HA 2070619-001 SGV14170915HA 2070619-001 SGV14192252HA 2070619-001 SGV14192259HA 2070619-001 SGV14192260HA 2070619-001 SGV14192261HA 2070619-001 SGV14192262HA 2070619-001 SGV14224431HA 2067388-001 SGV14224443HA 2067388-001 SGV14224447HA 2067388-001 SGV14224453HA 2067388-001 SGV14224461HA 2067388-001 SGV14224475HA 2067388-001 SGV14160541HA M1184207 SGV14181647HA M1184206 SGV14192741HA M1184207 SGV14192742HA M1184207 SGV14192761HA M1184207 SGV14193005HA M1184207 SGV14224436HA M1184207 SGV14224437HA M1184207 SGV14224438HA M1184207 SGV14224439HA M1184207 SGV14224466HA M1184207 SGV14224473HA M1184207 SGV14224476HA M1184207 SGV14160350HA M1226039 SGV14203396HA M1184844 SGV14203397HA M1184844 SGV14203398HA M1184844 SGV14203403HA M1184844 SGV14203406HA M1184844 SGV14203407HA M1184844 SGV14203411HA M1184844 SGV14203412HA M1184844 SGV14203414HA M1184844 SGV14160256HA 2070616-001 SGV14171153HA 2070616-001 SGV14182022HA 2065638-001 SGV14192247HA 2070616-001 SGV14192248HA 2070616-001 SGV14192249HA 2070616-001 SGV14192251HA 2070616-001 SGV14192253HA 2070616-001 SGV14192254HA 2070616-001 SGV14192256HA 2070616-001 SGV14192257HA 2070616-001 SGV14159967HA 2065628-001 SGV14150176HA M1184207 SGV14159975HA M1184207 SGV14148744HA M1179136-X SGV14150040HA M1184207 SGV14150046HA M1179136-X SGV14150048HA M1179136-X SGV14150058HA M1179136-X SGV14150036HA M1184207 SGV14150038HA M1184207 SGV14150061HA M1184207 SGV14159403HA M1217240 SGV14159478HA M1184207 SGV14159500HA M1184207 SGV14159690HA M1184207 SGV14159696HA M1184207 SGV14159701HA M1184207 SGV14159974HA M1184207 SGV14159980HA M1184207 SGV14159992HA M1184207 SGV14159996HA M1184207 SGV14159998HA M1184207 SGV14160343HA M1217240 SGV14160518HA M1184207 SGV14181892HA M1217240 SGV14181893HA M1217240 SGV14181894HA M1217240 SGV14181896HA M1217240 SGV14181899HA M1217240 SGV14181900HA M1217240 SGV14181901HA M1217240 SGV14181903HA M1217240 SGV14181906HA M1217240 SGV14181908HA M1217240 SGV14181909HA M1217240 SGV14181910HA M1217240 SGV14181911HA M1217240 SGV14182030HA M1184207 SGV14192277HA M1217240 SGV14192279HA M1217240 SGV14192280HA M1217240 SGV14192287HA M1217240 SGV14192291HA M1217240 SGV14192292HA M1217240 SGV14192293HA M1217240 SGV14192294HA M1217240 SGV14224446HA 2065636-001 SGV14224452HA M1184207 SGV14224456HA M1184207 SGV14224474HA M1184207 SGV14224480HA M1184207 SGV14150181HA 2065628-001 SGV14150063HA M1184207 SGV14150055HA 2065635-001 SGV14160530HA 2065635-001 SGV14160531HA 2065635-001 SGV14224449HA 2065635-001 SGV14150187HA 2065628-001 SGV14150196HA 2065628-001 SGV14160548HA 2065628-001 SGV14160223HA M1226032 SGV14160236HA M1226032 SGV14170902HA M1226032 SGV14170904HA M1226032 SGV14170906HA M1226032 SGV14170907HA M1226032 SGV14170924HA M1226032 SGV14170926HA M1226032 SGV14170927HA M1226032 SGV14170928HA M1226032 SGV14171160HA M1226032 SGV14224434HA M1184207 SGV14224472HA M1184207 SGV14181852HA 2065605-001 SGV14224440HA 2067394-001 SGV14224459HA 2067394-001 SGV14150053HA 2065628-001 SGV14150057HA M1184207 SGV14150078HA M1184207 SGV14150190HA M1184207 SGV14160327HA M1184207 SGV14192282HA M1217240 SGV14182006HA 2067395-001 SGV14192762HA 2067395-001 SGV14192994HA 2067395-001 SGV14193002HA 2067395-001 SGV14193003HA 2067395-001 SGV14224451HA 2067395-001 SGV14224478HA 2067395-001 SGV14224460HA M1184207 SGV14224470HA M1184207 SGV14150002HA 2065633-001 SGV14150174HA 2065633-001 SGV14159705HA 2065633-001 SGV14160246HA 2070611-001 SGV14160251HA 2070611-001 SGV14160253HA 2070611-001 SGV14170900HA 2070611-001 SGV14224467HA 2065633-001 SGV14150171HA 2065632-001 SGV14150186HA 2065632-001 SGV14150198HA 2065632-001 SGV14159710HA 2065632-001 SGV14170914HA 2070610-001 SGV14192731HA 2065632-001 SGV14192738HA M1184207 SGV14192977HA M1184207 SGV14149258HA M1184207 SGV14150003HA M1184207 SGV14150050HA M1184207 SGV14150052HA M1184207 SGV14150076HA M1184207 SGV14150167HA M1184207 SGV14150168HA M1184207 SGV14150172HA M1184207 SGV14150173HA M1184207 SGV14150175HA M1184207 SGV14150177HA M1184207 SGV14150178HA M1184207 SGV14150183HA M1184207 SGV14150188HA M1184207 SGV14150200HA M1184207 SGV14150202HA M1184207 SGV14159503HA M1184207 SGV14159700HA M1184207 SGV14159981HA M1184207 SGV14159986HA M1184207 SGV14160535HA M1184207 SGV14160549HA M1184207 SGV14182004HA M1184207 SGV14182014HA M1184207 SGV14182016HA M1184207 SGV14182018HA M1184207 SGV14182019HA M1184207 SGV14182020HA M1184207 SGV14182021HA M1184207 SGV14182023HA M1184207 SGV14182024HA M1184207 SGV14182026HA M1184207 SGV14182027HA M1184207 SGV14182031HA M1184207 SGV14192718HA M1184207 SGV14192721HA M1184207 SGV14192726HA M1184207 SGV14159407HA M1226039…

Recall started

Aug. 8, 2014

Device type

Analyzer, Gas, Oxygen, Gaseous-Phase

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

Consignees were sent on 8/8/2014 a GE Healthcare "Urgent Medical Device Correction" letter Ref# 36106 dated August 8, 2014. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions you can contact Technical Support at 1-800-558-7044 or your local Service Representative.

Recall number

Z-2617-2014

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

Source: FDA · Medical device enforcement report, recall number Z-2617-2014. The agency record governs; check it and the company before acting.