GE Healthcare…

Date

Sept. 25, 2013

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

GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.

Reason

GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.

Distribution pattern

Worldwide Distribution - USA (nationwide) including the states of : AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV,NH, NH, NM, NY, NC, OH, OK OR, PA, PR, SC, TN, TX, VA, WA, WV, WI and WY., and the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, COSTA RICA. CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MOROCCO, NETHERLAND, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VENEZUELA.

Quantity

9466 (3261 US, 6205 OUS)

Codes and lots

Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW10243449HA SEW10243450HA SEW10243458HA SEW10243476HA SEW10243477HA SEW10243478HA SEW10243479HA SEW10243481HA SEW10243482HA SEW10243484HA SEW10243486HA SEW10243487HA SEW10243489HA SEW10243490HA SEW10243491HA SEW10243492HA SEW10243496HA SEW10243498HA SEW10243499HA SEW10243500HA SEW10243503HA SEW10243504HA SEW10354687HA SEW10354688HA SEW10354694HA SEW10354695HA SEW10354696HA SEW10354697HA SEW10354701HA SEW10354704HA SEW10354706HA SEW10354707HA SEW10354708HA SEW10354709HA SEW10354712HA SEW10354713HA SEW10354717HA SEW10354722HA SEW10354724HA SEW10354728HA SEW10354730HA SEW10354736HA SEW10354738HA SEW10354740HA SEW10354741HA SEW10354746HA SEW10354749HA SEW10354751HA SEW10354752HA SEW10354754HA SEW10354756HA SEW10354757HA SEW10354758HA SEW10354759HA SEW10354760HA SEW10354761HA SEW10354762HA SEW10354763HA SEW10354764HA SEW10354767HA SEW10354768HA SEW10354773HA SEW10354774HA SEW10354775HA SEW10354776HA SEW10354777HA SEW10354778HA SEW10354780HA SEW10354781HA SEW10354783HA SEW10354784HA SEW10385221HA SEW10385223HA SEW10385225HA SEW10385226HA SEW10385227HA SEW10385228HA SEW10385229HA SEW10385230HA SEW10385231HA SEW10385232HA SEW10385234HA SEW10385236HA SEW10385256HA SEW10393672HA SEW10393675HA SEW10393682HA SEW10393747HA SEW10405542HA SEW10405618HA SEW10405648HA SEW10405669HA SEW10405670HA SEW10405673HA SEW10405696HA SEW10446451HA SEW10446466HA SEW10456855HA SEW10467083HA SEW10467133HA SEW10467151HA SEW10467216HA SEW10467289HA SEW10517983HA SEW10528081HA SEW10528111HA SEW11018531HA SEW11018538HA SEW11018545HA SEW11018644HA SEW11018645HA SEW11018646HA SEW11018647HA SEW11018650HA SEW11018651HA SEW11018652HA SEW11018653HA SEW11018702HA SEW11018721HA SEW11018725HA SEW11018729HA SEW11018730HA SEW11018731HA SEW11018732HA SEW11038851HA SEW11038910HA SEW11038918HA SEW11059070HA SEW11059082HA SEW11059083HA SEW11059084HA SEW11059128HA SEW11059129HA SEW11059130HA SEW11059131HA SEW11059132HA SEW11059133HA SEW11059134HA SEW11059135HA SEW11059136HA SEW11059137HA SEW11059138HA SEW11059139HA SEW11059140HA SEW11059141HA SEW11059142HA SEW11059143HA SEW11059144HA SEW11059145HA SEW11059148HA SEW11059149HA SEW11059150HA SEW11059151HA SEW11059153HA SEW11059155HA SEW11059156HA SEW11059157HA SEW11059158HA SEW11059159HA SEW11059160HA SEW11059161HA SEW11059164HA SEW11059165HA SEW11059166HA SEW11059168HA SEW11059169HA SEW11059171HA SEW11059172HA SEW11059173HA SEW11059174HA SEW11059175HA SEW11059177HA SEW11059178HA SEW11059179HA SEW11059180HA SEW11059181HA SEW11059182HA SEW11059183HA SEW11059184HA SEW11059185HA SEW11059186HA SEW11059187HA SEW11059188HA SEW11059189HA SEW11059190HA SEW11059191HA SEW11059192HA SEW11059193HA SEW11059194HA SEW11059198HA SEW11059200HA SEW11059202HA SEW11059204HA SEW11059206HA SEW11059208HA SEW11059212HA SEW11059213HA SEW11059215HA SEW11059216HA SEW11059217HA SEW11059218HA SEW11059219HA SEW11059220HA SEW11059221HA SEW11059226HA SEW11059227HA SEW11059233HA SEW11059234HA SEW11059235HA SEW11059236HA SEW11059242HA SEW11059243HA SEW11079351HA SEW11079352HA SEW11079353HA SEW11079354HA SEW11079355HA SEW11079357HA SEW11079358HA SEW11079359HA SEW11079360HA SEW11079361HA SEW11079363HA SEW11079365HA SEW11079366HA SEW11079367HA SEW11079368HA SEW11079369HA SEW11079370HA SEW11079371HA SEW11079372HA SEW11079373HA SEW11079375HA SEW11079376HA SEW11079377HA SEW11079378HA SEW11079379HA SEW11079380HA SEW11079381HA SEW11079382HA SEW11079383HA SEW11079384HA SEW11079387HA SEW11079392HA SEW11079394HA SEW11079396HA SEW11079408HA SEW11079415HA SEW11079417HA SEW11079418HA SEW11079419HA SEW11079420HA SEW11079421HA SEW11079422HA SEW11079423HA SEW11079424HA SEW11079425HA SEW11079426HA SEW11079427HA SEW11079428HA SEW11079429HA SEW11079430HA SEW11079431HA SEW11079433HA SEW11079436HA SEW11079441HA SEW11079450HA SEW11079451HA SEW11079453HA SEW11079456HA SEW11079458HA SEW11079459HA SEW11079462HA SEW11079463HA SEW11079464HA SEW11079465HA SEW11079466HA SEW11079467HA SEW11079468HA SEW11079469HA SEW11079470HA SEW11079471HA SEW11079472HA SEW11079473HA SEW11079474HA SEW11079475HA SEW11079476HA SEW11079477HA SEW11079478HA SEW11079479HA SEW11079481HA SEW11079484HA SEW11079486HA SEW11079487HA SEW11079488HA SEW11079489HA SEW11079490HA SEW11079491HA SEW11079493HA SEW11079495HA SEW11079496HA SEW11079501HA SEW11079504HA SEW11079505HA SEW11079507HA SEW11079509HA SEW11079510HA SEW11079511HA SEW11079512HA SEW11079513HA SEW11079515HA SEW11079519HA SEW11079521HA SEW11079524HA SEW11079526HA SEW11079528HA SEW11079529HA SEW11079532HA SEW11079533HA SEW11079534HA SEW11079535HA SEW11079536HA SEW11079537HA SEW11079538HA SEW11079540HA SEW11079541HA SEW11079545HA SEW11079546HA SEW11079547HA SEW11100001HA SEW11100003HA SEW11100004HA SEW11100008HA SEW11100009HA SEW11100010HA SEW11100011HA SEW11100012HA SEW11100013HA SEW11100014HA SEW11100015HA SEW11100016HA SEW11100017HA SEW11100021HA SEW11100022HA SEW11100023HA SEW11100024HA SEW11100025HA SEW11100026HA SEW11100027HA SEW11100028HA SEW11100029HA SEW11100030HA SEW11100032HA SEW11100033HA SEW11100034HA SEW11100035HA SEW11100036HA SEW11100037HA SEW11100039HA SEW11100040HA SEW11100041HA SEW11100043HA SEW11100044HA SEW11100045HA SEW11100046HA SEW11100047HA SEW11100048HA SEW11100049HA SEW11100050HA SEW11100051HA SEW11100058HA SEW11100067HA SEW11100068HA SEW11100069HA SEW11100070HA SEW11100071HA SEW11100072HA SEW11100084HA SEW11100087HA SEW11100088HA SEW11100094HA SEW11100096HA SEW11100099HA SEW11100101HA SEW11100103HA SEW11100105HA SEW11100106HA SEW11100107HA SEW11100108HA SEW11100109HA SEW11100110HA SEW11100131HA SEW11100132HA SEW11100133HA SEW11100135HA SEW11100136HA SEW11100137HA SEW11100138HA SEW11100141HA SEW11100155HA SEW11100157HA SEW11109957HA SEW11109958HA SEW11109959HA SEW11109960HA SEW11109961HA SEW11109962HA SEW11109963HA SEW11109964HA SEW11109965HA SEW11109966HA SEW11109968HA SEW11109969HA SEW11109970HA SEW11109971HA SEW11109972HA SEW11109974HA SEW11109975HA SEW11109977HA SEW11109978HA SEW11109979HA SEW11109980HA SEW11109982HA SEW11109983HA SEW11109985HA SEW11109987HA SEW11109988HA SEW11109989HA SEW11109990HA SEW11109991HA SEW11109992HA SEW11109993HA SEW11109996HA SEW11109998HA SEW11109999HA SEW11120439HA SEW11120440HA SEW11120443HA SEW11120454HA SEW11120464HA SEW11120465HA SEW11120467HA SEW11120468HA SEW11120470HA SEW11120471HA SEW11120472HA SEW11120474HA SEW11120475HA SEW11120476HA SEW11120478HA SEW11120479HA SEW11120481HA SEW11120482HA SEW11120484HA SEW11120485HA SEW11130590HA SEW11130591HA SEW11130592HA SEW11130593HA SEW11130594HA SEW11130598HA SEW11130600HA SEW11130602HA SEW11130613HA SEW11130614HA SEW11130615HA SEW11130617HA SEW11130619HA SEW11130625HA SEW11130630HA SEW11130632HA SEW11130633HA SEW11130634HA SEW11130637HA SEW11130638HA SEW11130639HA SEW11130640HA SEW11130641HA SEW11130647HA SEW11130652HA SEW11130655HA SEW11130665HA SEW11130675HA SEW11130676HA SEW11140789HA SEW11140791HA SEW11140792HA SEW11140834HA SEW11140837HA SEW11140840HA SEW11140841HA SEW11140843HA SEW11140852HA SEW11140853HA SEW11140858HA SEW11140859HA SEW11140860HA SEW11140861HA SEW11140862HA SEW11140864HA SEW11140870HA SEW11140873HA SEW11140877HA SEW11140882HA SEW11141008HA SEW11141009HA SEW11141014HA SEW11141056HA SEW11141057HA SEW11141065HA SEW11141070HA SEW11141071HA SEW11141072HA SEW11141073HA SEW11141074HA SEW11141077HA SEW11141078HA SEW11141079HA SEW11141080HA SEW11141081HA SEW11141086HA SEW11151188HA SEW11151191HA SEW11151192HA SEW11151193HA SEW11151194HA SEW11151195HA SEW11151196HA SEW11151197HA SEW11151198HA SEW11151199HA SEW11151200HA SEW11151202HA SEW11151203HA SEW11151204HA SEW11151205HA SEW11151207HA SEW11151208HA SEW11151209HA SEW11151210HA SEW11151211HA SEW11151212HA SEW11151213HA SEW11151214HA SEW11151215HA SEW11151216HA SEW11151217HA SEW11151219HA SEW11151231HA SEW11151233HA SEW11151236HA SEW11151237HA SEW11151239HA SEW11151255HA SEW11151257HA SEW11151263HA SEW11151266HA SEW11151269HA SEW11151274HA SEW11151284HA SEW11151285HA SEW11151286HA SEW11171442HA SEW11171454HA SEW11171455HA SEW11171456HA SEW11171457HA SEW11171462HA SEW11171464HA SEW11171472HA SEW11171478HA SEW11171480HA SEW11171486HA SEW11171499HA SEW11171503HA SEW11171507HA SEW11171511HA SEW11171525HA SEW11171526HA SEW11171527HA SEW11171530HA SEW11171531HA SEW11171532HA SEW11171533HA SEW11171534HA SEW11171539HA SEW11181752HA SEW11181753HA SEW11181758HA SEW11181770HA SEW11181773HA SEW11181774HA SEW11181775HA SEW11181776HA SEW11181778HA SEW11181779HA SEW11181781HA SEW11181782HA SEW11181785HA SEW11181787HA SEW11181788HA SEW11181790HA SEW11181791HA SEW11181792HA SEW11181794HA SEW11181797HA SEW11181800HA SEW11181813HA SEW11181823HA SEW11181828HA SEW11181834HA SEW11181837HA SEW11181838HA SEW11181839HA SEW11181842HA SEW11181848HA SEW11181852HA SEW11181854HA SEW11181856HA SEW11181857HA SEW11181858HA SEW11181859HA SEW11181862HA SEW11181863HA SEW11181866HA SEW11181867HA SEW11181869HA SEW11181871HA SEW11181873HA SEW11181875HA SEW11181876HA SEW11181882HA SEW11181886HA SEW11181892HA SEW11181894HA SEW11181895HA SEW11181896HA SEW11181897HA SEW11181898HA SEW11181899HA SEW11181900HA SEW11181904HA SEW11181905HA SEW11181906HA SEW11181908HA SEW11181909HA SEW11181910HA SEW11181911HA SEW11181912HA SEW11181913HA SEW11181914HA SEW11181915HA SEW11181916HA SEW11181917HA SEW11181919HA SEW11181920HA SEW11181921HA SEW11181922HA SEW11181923HA SEW11181925HA SEW11181926HA SEW11181927HA SEW11181928HA SEW11181930HA SEW11181932HA SEW11181936HA SEW11181941HA SEW11181942HA SEW11181943HA SEW11181947HA SEW11181949HA SEW11202202HA SEW11202203HA SEW11202204HA SEW11202220HA SEW11202222HA SEW11202223HA SEW11202228HA SEW11202230HA SEW11202232HA SEW11202258HA SEW11202260HA SEW11202263HA SEW11202264HA SEW11202266HA SEW11202277HA SEW11202283HA SEW11202286HA SEW11202287HA SEW11202288HA SEW11202290HA SEW11202291HA SEW11202294HA SEW11202296HA SEW11202298HA SEW11202299HA SEW11202301HA SEW11202304HA SEW11202306HA SEW11202307HA SEW11202309HA SEW11202310HA SEW11202313HA SEW11202317HA SEW11202319HA SEW11202320HA SEW11202321HA SEW11202322HA SEW11202323HA SEW11202325HA SEW11202328HA SEW11202329HA SEW11202331HA SEW11202332HA SEW11202333HA SEW11202334HA SEW11202335HA SEW11202336HA SEW11202337HA SEW11202338HA SEW11202340HA SEW11202341HA SEW11202343HA SEW11202346HA SEW11202347HA SEW11202348HA SEW11202349HA SEW11202350HA SEW11202351HA SEW11202352HA SEW11202353HA SEW11202356HA SEW11202357HA SEW11202358HA SEW11202359HA SEW11202360HA SEW11202361HA SEW11202362HA SEW11202363HA SEW11202364HA SEW11202365HA SEW11202366HA SEW11202368HA SEW11202369HA SEW11202370HA SEW11202371HA SEW11202372HA SEW11202378HA SEW11202379HA SEW11202380HA SEW11202381HA SEW11202383HA SEW11202384HA SEW11202385HA SEW11202390HA SEW11202391HA SEW11202394HA SEW11202395HA SEW11202397HA SEW11202398HA SEW11202399HA SEW11202400HA SEW11202401HA SEW11202682HA SEW11202687HA SEW11202690HA SEW11202693HA SEW11202696HA SEW11202697HA SEW11202700HA SEW11202702HA SEW11202703HA SEW11202704HA SEW11202705HA SEW11202706HA SEW11202707HA SEW11202708HA SEW11202709HA SEW11202711HA SEW11202712HA SEW11202713HA SEW11202715HA SEW11202716HA SEW11202717HA SEW11202719HA SEW11202728HA SEW11202731HA SEW11202736HA SEW11202737HA SEW11202739HA SEW11202740HA SEW11202741HA SEW11202742HA SEW11202744HA SEW11202745HA SEW11202746HA SEW11202747HA SEW11202749HA SEW11202750HA SEW11202753HA SEW11202769HA SEW11202775HA SEW11202778HA SEW11202780HA SEW11222997HA SEW11222999HA SEW11223011HA SEW11223019HA SEW11223020HA SEW11223022HA SEW11223070HA SEW11223081HA SEW11223082HA SEW11223085HA SEW11223086HA SEW11223092HA SEW11223103HA SEW11223106HA SEW11223107HA SEW11223108HA SEW11223121HA SEW11223122HA SEW11223123HA SEW11223128HA SEW11223129HA SEW11223130HA SEW11223132HA SEW11223134HA SEW11223136HA SEW11223140HA SEW11243338HA SEW11243339HA SEW11243341HA SEW11243343HA SEW11243344HA SEW11243345HA SEW11243348HA SEW11243349HA SEW11243350HA SEW11243353HA SEW11243354HA SEW11243357HA SEW11243358HA SEW11243359HA SEW11243360HA SEW11243361HA SEW11243362HA SEW11243364HA SEW11243365HA…

Recall started

July 12, 2012

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

GE Healthcare sent an Important Product Information letter dated July 12, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will provide a software and hardware correction at no charge once it is available. We will contact you to arrange for this correction. If you have any questions regarding this notification, please contact Technical Support (1-800- 558-7044) or your local Service Representative

Recall number

Z-2256-2013

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

Source: FDA · Medical device enforcement report, recall number Z-2256-2013. The agency record governs; check it and the company before acting.