GE Healthcare…

Date

March 25, 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 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field Replaceable Unit P/Ns 408930-001 Rev E, 408930-002 Rev C. UPDATE: 3-30-2015: T2100 & T2000 Treadmills with power cord part numbers 408930-001, 408930-002, or 2028038-008 Also Field Replaceable Unit P/Ns 408930-001, 408930-002 Product Usage: Used for Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.

Reason

Potential safety issue due to improper assembly associated with the power cords of T2100 and T2000 Treadmills.

Distribution pattern

CONTINENTAL USA DISTRIBUTION INCLUDING DC AND PR. OUS: ARGENTINA AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BHUTAN, BOLIVIA, BRAZIL, BRUNEI, CAMBODIA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, SPAIN, FINLAND, FRANCE, UNITED KIGDOM, GERMANY, GUAM, GUYANA, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, ITLAY, JAMAICA, JAPAN, REPUBLIC OF KOREA, MACAU, MALYAYSIA, MARTINIQUE, MEXICO, MONACO, MYANMAR, NEPAL, NEW ZEALANAD, NICARAGUA, PANAMA, PARAGUAY, PERU, PHILIPPINES, PORTUGAL, RUSSIA. SINGAPORE, SOUTH KOREA, SRILANKA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, URUGUAY, UZBEKISTAN, VENEZUELA, VIET NAM.

Quantity

13,345 (5,495 units US, 7,850 units OUS)

Codes and lots

Mfg Lot or Serial # 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-001 408930-002 408930-001 408930-001 408930-001 SBC0162242SA SBC05370011SA SBC05370013SA SBC05370017SA SBC05370018SA SBC05400001SA SBC05400003SA SBC05440023SA SBC05440024SA SBC05440025SA SBC05440026SA SBC05440028SA SBC05440029SA SBC05440030SA SBC05440032SA SBC05450034SA SBC05450035SA SBC05450036SA SBC05450037SA SBC05450038SA SBC05450039SA SBC05450041SA SBC05450043SA SBC05450044SA SBC05450047SA SBC05450049SA SBC05450050SA SBC05450054SA SBC05450055SA SBC05450060SA SBC05450064SA SBC05450065SA SBC05450068SA SBC05450069SA SBC05450073SA SBC05450074SA SBC05460075SA SBC05460076SA SBC05460077SA SBC05460078SA SBC05460079SA SBC05460080SA SBC05460081SA SBC05460082SA SBC05460086SA SBC05460090SA SBC05460101SA SBC05470113SA SBC05470115SA SBC05470117SA SBC05470120SA SBC05470126SA SBC05470130SA SBC05470134SA SBC05470136SA SBC05470140SA SBC05480151SA SBC05480153SA SBC05480158SA SBC05480159SA SBC05480161SA SBC05480165SA SBC05480166SA SBC05480168SA SBC05480175SA SBC05480176SA SBC05480181SA SBC05480182SA SBC05480183SA SBC05480184SA SBC05480186SA SBC05480189SA SBC05480192SA SBC05490193SA SBC05490194SA SBC05490195SA SBC05490198SA SBC05490199SA SBC05490200SA SBC05490202SA SBC05490213SA SBC05490216SA SBC05490217SA SBC05490218SA SBC05490219SA SBC05490221SA SBC05490222SA SBC05490223SA SBC05490224SA SBC05490227SA SBC05490230SA SBC05490232SA SBC05490233SA SBC05490236SA SBC05490237SA SBC05490241SA SBC05490246SA SBC05490247SA SBC05500249SA SBC05500251SA SBC05500252SA SBC05500253SA SBC05500254SA SBC05500255SA SBC05500256SA SBC05500257SA SBC05500260SA SBC05500261SA SBC05500262SA SBC05500263SA SBC05500264SA SBC05500266SA SBC05500268SA SBC05500271SA SBC05500272SA SBC05500273SA SBC05500276SA SBC05500280SA SBC05500281SA SBC05500282SA SBC05500283SA SBC05500292SA SBC05500294SA SBC05500296SA SBC05500299SA.DEL SBC05500303SA SBC05500306SA SBC05500308SA SBC05500309SA SBC05500310SA SBC05500313SA SBC05500315SA SBC05500321SA SBC05500322SA SBC05500323SA SBC05500325SA SBC05500326SA SBC05500327SA SBC05500328SA SBC05500329SA SBC05500330SA SBC05500332SA SBC05500333SA SBC05500334SA SBC05500336SA SBC05500337SA SBC05500339SA SBC05500340SA SBC05500341SA SBC05500342SA SBC05500344SA SBC05500345SA SBC05500348SA SBC05500350SA SBC05500351SA SBC05500352SA SBC05500353SA SBC05510356SA SBC05510357SA SBC05510359SA SBC05510362SA SBC05510363SA SBC05510364SA SBC05510365SA SBC05510366SA SBC05510367SA SBC05510368SA SBC05510373SA SBC05510374SA SBC05510375SA SBC05510376SA SBC05510377SA SBC05510378SA.DEL SBC05510379SA SBC05510384SA SBC06020384SA SBC06020388SA SBC06020389SA SBC06020398SA SBC06020400SA SBC06020402SA SBC06020404SA SBC06020406SA SBC06030413SA SBC06030418SA SBC06030423SA SBC06030427SA SBC06030429SA SBC06030431SA SBC06030434SA SBC06030436SA SBC06040440SA SBC06040441SA SBC06040445SA SBC06040447SA SBC06040450SA SBC06040453SA SBC06040456SA SBC06040457SA SBC06040459SA SBC06040461SA SBC06040462SA SBC06040463SA SBC06040465SA SBC06050472SA SBC06050474SA SBC06050475SA SBC06050477SA SBC06050479SA SBC06050480SA SBC06050481SA SBC06050482SA SBC06050483SA SBC06050485SA SBC06050486SA SBC06050489SA SBC06050491SA SBC06060497SA SBC06060499SA SBC06060504SA SBC06060506SA SBC06060507SA SBC06060509SA SBC06060514SA SBC06060516SA SBC06060518SA SBC06060520SA SBC06060525SA SBC06070528SA SBC06070530SA SBC06070533SA SBC06070534SA SBC06070537SA SBC06070540SA SBC06070542SA SBC06070547SA SBC06070550SA SBC06070554SA SBC06070555SA SBC06070556SA SBC06070557SA SBC06070558SA SBC06070559SA SBC06080566SA SBC06080567SA SBC06080570SA SBC06080570SA.DEL SBC06080573SA SBC06080582SA SBC06080586SA SBC06080588SA SBC06080590SA SBC06080594SA SBC06080599SA SBC06080600SA SBC06080601SA SBC06090609SA SBC06090610SA SBC06090616SA SBC06090618SA SBC06090621SA SBC06090622SA SBC06100625SA SBC06100627SA SBC06100628SA SBC06100629SA SBC06100631SA SBC06100632SA SBC06100633SA SBC06100634SA SBC06100635SA SBC06100635SASBW06101426SA SBC06100636SA SBC06100637SA SBC06100638SA SBC06100639SA SBC06100640SA SBC06100642SA SBC06100644SA SBC06100645SA SBC06100646SA SBC06100648SA SBC06100649SA SBC06110650SA SBC06110653SA SBC06110655SA SBC06110656SA SBC06110657SA SBC06110658SA SBC06110659SA SBC06110660SA SBC06110661SA SBC06110662SA SBC06110663SA SBC06120665SA SBC06120666SA SBC06120668SA SBC06120669SA SBC06120670SA SBC06120671SA SBC06120672SA SBC06120673SA SBC06120674SA SBC06120675SA SBC06120676SA SBC06120677SA SBC06120678SA SBC06120681SA SBC06120682SA SBC06120683SA SBC06120684SA SBC06120687SA SBC06120688SA SBC06120689SA SBC06120690SA SBC06120691SA SBC06120692SA SBC06120694SA SBC06120695SA SBC06120696SA SBC06120697SA SBC06120698SA SBC06120699SA SBC06120700SA SBC06120701SA SBC06120702SA SBC06120704SA SBC06120708SA SBC06130710SA SBC06130711SA SBC06130713SA SBC06130722SA SBC06130726SA SBC06130732SA SBC06130733SA SBC06130740SA SBC06130743SA SBC06130747SA SBC06130749SA SBC06130750SA SBC06130751SA SBC06140752SA SBC06140753SA SBC06140755SA SBC06140757SA SBC06140759SA SBC06140762SA SBC06140763SA SBC06140767SA SBC06140768SA SBC06140769SA SBC06140771SA SBC06140775SA SBC06140777SA SBC06150781SA.DEL SBC06150783SA SBC06150784SA SBC06150785SA SBC06150786SA SBC06150787SA SBC06150788SA SBC06150789SA SBC06150790SA SBC06160793SA SBC06160794SA SBC06160797SA SBC06160801SA SBC06160810SA SBC06160811SA SBC06160815SA SBC06160817SA SBC06170819SA SBC06170820SA SBC06170821SA SBC06170823SA SBC06170825SA SBC06170828SA SBC06170831SA SBC06170835SA SBC06170839SA SBC06170840SA SBC06170842SA SBC06170843SA SBC06170844SA SBC06170846SA SBC06170847SA SBC06170848SA SBC06170850SA SBC06170854SA SBC06170856SA SBC06170857SA SBC06170858SA SBC06180859SA SBC06180860SA SBC06180861SA SBC06180862SA SBC06180863SA SBC06180864SA SBC06180865SA SBC06180866SA SBC06180867SA SBC06180869SA SBC06180870SA SBC06180872SA SBC06180873SA SBC06180875SA SBC06180878SA SBC06180880SA SBC06180882SA SBC06180885SA SBC06180886SA SBC06180890SA SBC06180891SA SBC06190895SA SBC06190896SA SBC06190897SA SBC06190898SA SBC06190903SA SBC06190904SA SBC06190909SA SBC06190911SA SBC06190914SA SBC06190915SA SBC06190916SA SBC06190921SA SBC06190926SA SBC06190927SA SBC06190928SA SBC06190929SA SBC06190932SA SBC06200933SA SBC06200934SA SBC06200935SA SBC06200938SA SBC06200939SA SBC06200940SA SBC06200942SA SBC06210947SA SBC06210954SA SBC06210958SA SBC06210960SA SBC06210962SA SBC06210963SA SBC06210964SA SBC06210965SA SBC06210966SA SBC06210967SA SBC06210968SA SBC06210969SA SBC06210971SA SBC06210972SA SBC06210978SA SBC06210979SA SBC06210980SA SBC06220981SA SBC06220983SA SBC06220984SA SBC06220987SA SBC06220990SA SBC06220991SA 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 SBC06241056SA SBC06241057SA SBC06241059SA SBC06241061SA SBC06241062SA SBC06241063SA SBC06241064SA SBC06241065SA SBC06241066SA SBC06241067SA SBC06241068SA SBC06241085SA SBC06241089SA SBC06241090SA SBC06251091SA SBC06251092SA SBC06251093SA SBC06251094SA SBC06251096SA SBC06251097SA SBC06251098SA SBC06251099SA SBC06251100SA SBC06251102SA SBC06251105SA SBC06251106SA SBC06251107SA SBC06251108SA SBC06251109SA SBC06251112SA SBC06251113SA SBC06251114SA SBC06251115SA SBC06251116SA SBC06251117SA SBC06251118SA SBC06251119SA SBC06251120SA SBC06251125SA SBC06251126SA SBC06251128SA SBC06251129SA SBC06251130SA SBC06261139SA SBC06261140SA SBC06261144SA SBC06261145SA 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SBC06311255SA SBC06311256SA SBC06311257SA SBC06311263SA SBC06321265SA SBC06321268SA SBC06321271SA SBC06321273SA SBC06321275SA SBC06321278SA SBC06321280SA SBC06321283SA SBC06321284SA SBC06321285SA SBC06321286SA SBC06331288SA SBC06331289SA SBC06331290SA SBC06331291SA SBC06331292SA SBC06331293SA SBC06331294SA SBC06331295SA SBC06331296SA SBC06331297SA SBC06331299SA SBC06331300SA SBC06331301SA SBC06331305SA SBC06331307SA SBC06331308SA SBC06331309SA SBC06331310SA SBC06331312SA SBC06331313SA SBC06341314SA SBC06341315SA SBC06341317SA SBC06341319SA SBC06341320SA SBC06341321SA SBC06341323SA SBC06341324SA SBC06341325SA SBC06341326SA SBC06341327SA SBC06341328SA SBC06351330SA SBC06351331SA SBC06351332SA SBC06351334SA SBC06351335SA SBC06351336SA SBC06351338SA SBC06351339SA SBC06351341SA SBC06351342SA SBC06351343SA SBC06351344SA SBC06361345SA SBC06361346SA SBC06361347SA SBC06361348SA SBC06361349SA SBC06361350SA SBC06361352SA SBC06361353SA SBC06361354SA SBC06361357SA SBC06361360SA SBC06361361SA SBC06361362SA SBC06361363SA SBC06361364SA…

Recall started

Feb. 16, 2015

Device type

Treadmill, Powered

Root cause (FDA)

Process control

What the company told customers

GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#30073 dated February 16, 2015. The letter was addressed to Director of Biomedical Engineering, Chief of Nursing, & 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. UPDATE 3-30-2015: A second revised letter was sent on March 31, 2015. NOTE: this revised notification includes an update to the Affected Product Details section to include all revisions of power cords manufactured within the date range indicated. (The previous notification referenced only revisions B, C, & E).

Recall number

Z-1285-2015

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

Source: FDA · Medical device enforcement report, recall number Z-1285-2015. The agency record governs; check it and the company before acting.