GE Healthcare…

Date

July 1, 2015

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

Product

GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

Reason

GE Healthcare has recently become aware of a potential safety issue due to uncontrolled motion of the walking belt on your T2100 Treadmill.

Distribution pattern

Nationwide Distribution including Guam, DC, and Puerto Rico. OUS: VIET NAM, VENEZUELA, UZBEKISTAN, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TRINIDAD & TOBAGO, THAILAND, TAIWAN EL SALVADOR, SRILANKA, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, RUSSIA, PORTUGAL PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, NEW ZEALAND, NICARAGUA, NEPAL, MYANMAR, MOROCCO, MEXICO, MARTINIQUE, MALAYSIA, LEBANON, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HON GONG, GERMANY, FRANCE, FINLAND, ETHIOPIA, EGYPT, ECUADOR, DOMINICAN REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE , CAYMAN ISLAND , CANADA, CAMBODIA, BRUNEI DARUSSALAM, BRAZIL, BOLIVIA, BHUTAN, BANGLADESH, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.

Quantity

11,423 (5,540 units US, 5,883 units OUS

Codes and lots

Mfg Lot or Serial # SBC05370011SA SBC05370013SA SBC05370014SA SBC05370015SA SBC05370017SA SBC05370018SA SBC05370019SA SBC05370021SA SBC05370022SA SBC05400001SA SBC05400003SA SBC05400004SA SBC05400006SA SBC05400007SA SBC05400008SA SBC05400009SA SBC05400010SA SBC05440023SA SBC05440024SA SBC05440025SA SBC05440026SA SBC05440027SA SBC05440028SA SBC05440029SA SBC05440030SA SBC05440032SA SBC05450034SA SBC05450035SA SBC05450036SA SBC05450037SA SBC05450038SA SBC05450039SA SBC05450041SA SBC05450042SA SBC05450043SA SBC05450044SA SBC05450045SA SBC05450046SA SBC05450047SA SBC05450048SA SBC05450049SA SBC05450050SA SBC05450051SA SBC05450054SA SBC05450055SA SBC05450056SA SBC05450058SA SBC05450060SA SBC05450061SA SBC05450062SA SBC05450064SA SBC05450065SA SBC05450067SA SBC05450068SA SBC05450069SA SBC05450072SA SBC05450073SA SBC05450074SA SBC05460075SA SBC05460076SA SBC05460077SA SBC05460078SA SBC05460079SA SBC05460080SA SBC05460081SA SBC05460082SA SBC05460084SA SBC05460085SA SBC05460086SA SBC05460090SA SBC05460091SA SBC05460101SA SBC05460104SA SBC05460108SA SBC05460109SA SBC05470113SA SBC05470115SA SBC05470117SA SBC05470119SA SBC05470120SA SBC05470122SA SBC05470126SA SBC05470130SA SBC05470131SA SBC05470134SA SBC05470136SA SBC05470138SA SBC05470140SA SBC05470141SA SBC05470142SA SBC05470143SA SBC05470144SA SBC05470145SA SBC05470146SA SBC05470147SA SBC05470148SA SBC05480151SA SBC05480152SA SBC05480153SA SBC05480154SA SBC05480155SA SBC05480158SA SBC05480159SA SBC05480161SA SBC05480165SA SBC05480166SA SBC05480168SA SBC05480173SA SBC05480174SA SBC05480175SA SBC05480176SA SBC05480177SA SBC05480181SA SBC05480182SA SBC05480183SA SBC05480184SA SBC05480186SA SBC05480187SA SBC05480189SA SBC05480192SA SBC05490193SA SBC05490194SA SBC05490195SA SBC05490196SA SBC05490198SA SBC05490199SA SBC05490200SA SBC05490202SA SBC05490213SA SBC05490216SA SBC05490217SA SBC05490218SA SBC05490219SA SBC05490220SA SBC05490221SA SBC05490222SA SBC05490223SA SBC05490224SA SBC05490225SA SBC05490227SA SBC05490228SA SBC05490229SA SBC05490230SA SBC05490232SA SBC05490233SA SBC05490234SA SBC05490236SA SBC05490237SA SBC05490239SA SBC05490241SA SBC05490244SA SBC05490245SA SBC05490246SA SBC05490247SA SBC05500249SA SBC05500250SA SBC05500251SA SBC05500252SA SBC05500253SA SBC05500254SA SBC05500255SA SBC05500256SA SBC05500257SA SBC05500258SA SBC05500259SA SBC05500260SA SBC05500261SA SBC05500262SA SBC05500263SA SBC05500264SA SBC05500266SA SBC05500268SA SBC05500271SA SBC05500272SA SBC05500273SA SBC05500274SA SBC05500275SA SBC05500276SA SBC05500279SA SBC05500280SA SBC05500281SA SBC05500282SA SBC05500283SA SBC05500285SA SBC05500286SA SBC05500288SA SBC05500289SA SBC05500291SA SBC05500292SA SBC05500293SA SBC05500294SA SBC05500295SA SBC05500296SA SBC05500298SA SBC05500299SA SBC05500300SA SBC05500303SA SBC05500304SA SBC05500305SA SBC05500306SA SBC05500307SA SBC05500308SA SBC05500309SA SBC05500310SA SBC05500311SA SBC05500312SA SBC05500313SA SBC05500314SA SBC05500315SA SBC05500316SA SBC05500317SA SBC05500318SA SBC05500320SA SBC05500321SA SBC05500322SA SBC05500323SA SBC05500324SA SBC05500325SA SBC05500326SA SBC05500327SA SBC05500328SA SBC05500329SA SBC05500330SA SBC05500331SA SBC05500332SA SBC05500333SA SBC05500334SA SBC05500335SA SBC05500336SA SBC05500337SA SBC05500338SA SBC05500339SA SBC05500340SA SBC05500341SA SBC05500342SA SBC05500343SA SBC05500344SA SBC05500345SA SBC05500347SA SBC05500348SA SBC05500349SA SBC05500350SA SBC05500351SA SBC05500352SA SBC05500353SA SBC05510355SA SBC05510356SA SBC05510357SA SBC05510358SA SBC05510359SA SBC05510361SA SBC05510362SA SBC05510363SA SBC05510364SA SBC05510365SA SBC05510366SA SBC05510367SA SBC05510368SA SBC05510372SA SBC05510373SA SBC05510374SA SBC05510375SA SBC05510376SA SBC05510377SA SBC05510378SA SBC05510379SA SBC05510381SA SBC05510382SA SBC05510383SA SBC05510384SA SBC06020384SA SBC06020386SA SBC06020387SA SBC06020388SA SBC06020389SA SBC06020390SA SBC06020391SA SBC06020392SA SBC06020394SA SBC06020396SA SBC06020398SA SBC06020399SA SBC06020400SA SBC06020401SA SBC06020402SA SBC06020403SA SBC06020404SA SBC06020405SA SBC06020406SA SBC06020407SA SBC06020408SA SBC06020409SA SBC06030411SA SBC06030412SA SBC06030413SA SBC06030416SA SBC06030418SA SBC06030419SA SBC06030420SA SBC06030421SA SBC06030422SA SBC06030423SA SBC06030424SA SBC06030426SA SBC06030427SA SBC06030428SA SBC06030429SA SBC06030430SA SBC06030431SA SBC06030432SA SBC06030433SA SBC06030434SA SBC06030435SA SBC06030436SA SBC06030437SA SBC06030438SA SBC06030439SA SBC06040440SA SBC06040441SA SBC06040442SA SBC06040443SA SBC06040444SA SBC06040445SA SBC06040447SA SBC06040448SA SBC06040449SA SBC06040450SA SBC06040451SA SBC06040452SA SBC06040453SA SBC06040454SA SBC06040456SA SBC06040457SA SBC06040459SA SBC06040460SA SBC06040461SA SBC06040462SA SBC06040463SA SBC06040464SA SBC06040465SA SBC06040466SA SBC06040467SA SBC06050469SA SBC06050472SA SBC06050474SA SBC06050475SA SBC06050476SA SBC06050477SA SBC06050478SA SBC06050479SA SBC06050480SA SBC06050481SA SBC06050482SA SBC06050483SA SBC06050484SA SBC06050485SA SBC06050486SA SBC06050487SA SBC06050488SA SBC06050489SA SBC06050490SA SBC06050491SA SBC06050494SA SBC06050496SA SBC06060497SA SBC06060498SA SBC06060499SA SBC06060501SA SBC06060502SA SBC06060503SA SBC06060504SA SBC06060505SA SBC06060506SA SBC06060507SA SBC06060508SA SBC06060509SA SBC06060510SA SBC06060512SA SBC06060513SA SBC06060514SA SBC06060515SA SBC06060516SA SBC06060518SA SBC06060519SA SBC06060520SA SBC06060522SA SBC06060524SA SBC06060525SA SBC06070526SA SBC06070528SA SBC06070529SA SBC06070530SA SBC06070532SA SBC06070533SA SBC06070534SA SBC06070535SA SBC06070536SA SBC06070537SA SBC06070538SA SBC06070540SA SBC06070541SA SBC06070542SA SBC06070543SA SBC06070544SA SBC06070546SA SBC06070547SA SBC06070548SA SBC06070550SA SBC06070553SA SBC06070554SA SBC06070555SA SBC06070556SA SBC06070557SA SBC06070558SA SBC06070559SA SBC06080562SA SBC06080566SA SBC06080567SA SBC06080569SA SBC06080570SA SBC06080571SA SBC06080573SA SBC06080575SA SBC06080577SA SBC06080578SA SBC06080579SA SBC06080581SA SBC06080582SA SBC06080583SA SBC06080584SA SBC06080585SA SBC06080586SA SBC06080588SA SBC06080590SA SBC06080591SA SBC06080592SA SBC06080593SA SBC06080594SA SBC06080595SA SBC06080599SA SBC06080600SA SBC06080601SA SBC06080602SA SBC06090604SA SBC06090605SA SBC06090606SA SBC06090607SA SBC06090608SA SBC06090609SA SBC06090610SA SBC06090611SA SBC06090612SA SBC06090613SA SBC06090614SA SBC06090615SA SBC06090616SA SBC06090617SA SBC06090618SA SBC06090619SA SBC06090620SA SBC06090621SA SBC06090622SA SBC06100624SA SBC06100625SA SBC06100626SA SBC06100627SA SBC06100628SA SBC06100629SA SBC06100630SA SBC06100631SA SBC06100632SA SBC06100633SA SBC06100634SA SBC06100635SA SBC06100636SA SBC06100637SA SBC06100638SA SBC06100639SA SBC06100640SA SBC06100641SA SBC06100642SA SBC06100644SA SBC06100645SA SBC06100646SA SBC06100648SA SBC06100649SA SBC06110650SA SBC06110651SA SBC06110652SA SBC06110653SA SBC06110655SA SBC06110656SA SBC06110657SA SBC06110658SA SBC06110659SA SBC06110660SA SBC06110661SA SBC06110662SA SBC06110663SA SBC06110664SA SBC06120665SA SBC06120666SA SBC06120668SA SBC06120669SA SBC06120670SA SBC06120671SA SBC06120672SA SBC06120673SA SBC06120674SA SBC06120675SA SBC06120676SA SBC06120677SA SBC06120678SA SBC06120680SA SBC06120681SA SBC06120682SA SBC06120683SA SBC06120684SA SBC06120686SA SBC06120687SA SBC06120688SA SBC06120689SA SBC06120690SA SBC06120691SA SBC06120692SA SBC06120694SA SBC06120695SA SBC06120696SA SBC06120697SA SBC06120698SA SBC06120699SA SBC06120700SA SBC06120701SA SBC06120702SA SBC06120703SA SBC06120704SA SBC06120708SA SBC06130710SA SBC06130711SA SBC06130712SA SBC06130713SA SBC06130715SA SBC06130716SA SBC06130718SA SBC06130720SA SBC06130722SA SBC06130723SA SBC06130724SA SBC06130725SA SBC06130726SA SBC06130728SA SBC06130729SA SBC06130732SA SBC06130733SA SBC06130736SA SBC06130740SA SBC06130742SA SBC06130743SA SBC06130745SA SBC06130747SA SBC06130748SA SBC06130749SA SBC06130750SA SBC06130751SA SBC06140752SA SBC06140753SA SBC06140755SA SBC06140756SA SBC06140757SA SBC06140758SA SBC06140759SA SBC06140760SA SBC06140761SA SBC06140762SA SBC06140763SA SBC06140764SA SBC06140767SA SBC06140768SA SBC06140769SA SBC06140771SA SBC06140774SA SBC06140775SA SBC06140776SA SBC06140777SA SBC06140778SA SBC06150780SA SBC06150781SA SBC06150782SA SBC06150783SA SBC06150784SA SBC06150785SA SBC06150786SA SBC06150787SA SBC06150788SA SBC06150789SA SBC06150790SA SBC06160793SA SBC06160794SA SBC06160797SA SBC06160800SA SBC06160801SA SBC06160810SA SBC06160811SA SBC06160815SA SBC06160817SA SBC06170819SA SBC06170820SA SBC06170821SA SBC06170823SA SBC06170825SA SBC06170828SA SBC06170831SA SBC06170835SA SBC06170838SA SBC06170839SA SBC06170840SA SBC06170842SA SBC06170843SA SBC06170844SA SBC06170846SA SBC06170847SA SBC06170848SA SBC06170849SA SBC06170850SA SBC06170851SA SBC06170854SA SBC06170856SA SBC06170857SA SBC06170858SA SBC06180859SA SBC06180860SA SBC06180861SA SBC06180862SA SBC06180863SA SBC06180864SA SBC06180865SA SBC06180866SA SBC06180867SA SBC06180868SA SBC06180869SA SBC06180870SA SBC06180871SA SBC06180872SA SBC06180873SA SBC06180874SA SBC06180875SA SBC06180876SA SBC06180877SA SBC06180878SA SBC06180880SA SBC06180882SA SBC06180884SA SBC06180885SA SBC06180886SA SBC06180887SA SBC06180888SA SBC06180889SA SBC06180890SA SBC06180891SA SBC06180893SA SBC06180894SA SBC06190895SA SBC06190896SA SBC06190897SA SBC06190898SA SBC06190899SA SBC06190900SA SBC06190902SA SBC06190903SA SBC06190904SA SBC06190905SA SBC06190907SA SBC06190908SA SBC06190909SA SBC06190910SA SBC06190911SA SBC06190912SA SBC06190913SA SBC06190914SA SBC06190915SA SBC06190916SA SBC06190917SA SBC06190918SA SBC06190919SA SBC06190920SA SBC06190921SA SBC06190922SA SBC06190923SA SBC06190925SA SBC06190926SA SBC06190927SA SBC06190928SA SBC06190929SA SBC06190930SA SBC06190931SA SBC06190932SA SBC06200933SA SBC06200934SA SBC06200935SA SBC06200936SA SBC06200937SA SBC06200938SA SBC06200939SA SBC06200940SA SBC06200941SA SBC06200942SA SBC06200944SA SBC06210945SA SBC06210946SA SBC06210947SA SBC06210949SA SBC06210951SA SBC06210952SA SBC06210953SA SBC06210954SA SBC06210955SA SBC06210956SA SBC06210957SA SBC06210958SA SBC06210959SA SBC06210960SA SBC06210961SA SBC06210962SA SBC06210963SA SBC06210964SA SBC06210965SA SBC06210966SA SBC06210967SA SBC06210968SA SBC06210969SA SBC06210970SA SBC06210971SA SBC06210972SA SBC06210973SA SBC06210977SA SBC06210978SA SBC06210979SA SBC06210980SA SBC06220981SA SBC06220982SA SBC06220983SA SBC06220984SA SBC06220985SA SBC06220986SA SBC06220987SA SBC06220990SA SBC06220991SA SBC06220992SA SBC06220993SA SBC06220995SA SBC06220996SA SBC06220997SA SBC06220998SA SBC06230999SA SBC06231002SA SBC06231003SA SBC06231005SA SBC06231008SA SBC06231009SA SBC06231011SA SBC06231014SA SBC06231015SA SBC06231019SA SBC06231022SA SBC06231026SA SBC06231027SA SBC06231029SA SBC06231031SA SBC06231032SA SBC06231033SA SBC06231034SA SBC06231039SA SBC06241044SA SBC06241046SA SBC06241049SA SBC06241050SA SBC06241051SA SBC06241052SA SBC06241053SA SBC06241055SA 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SBC06291184SA SBC06291186SA SBC06291187SA SBC06291188SA…

Recall started

March 12, 2015

Device type

Treadmill, Powered

Root cause (FDA)

Device Design

What the company told customers

General Healthcare sent an Urgent Medical Device Correction letter (GEHC Ref# 30074) dated March 12, 2015, to all affected consignees. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing and Healthcare Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-1825-2015

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

Source: FDA · Medical device enforcement report, recall number Z-1825-2015. The agency record governs; check it and the company before acting.