Retiro De Equipo (Recall) de Device Recall Chorus Mobile Patient Lifter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Arjo, Inc. dba ArjoHuntleigh.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    62116
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1948-2012
  • Fecha de inicio del evento
    2012-06-29
  • Fecha de publicación del evento
    2012-07-06
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2018-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lift, patient, non-ac-powered - Product Code FSA
  • Causa
    Arjohuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
  • Acción
    ArjoHuntleigh sent an "URGENT FIELD CORRECTION RECALL" notice dated June 25, 2012, to all affected customers via UPS Ground on June 29, 2012. The notice informed the accounts of the potential for severe patient injury if the proactive knee pad support is removed from the lift without the removal of the knee pad support bracket. The accounts were reminded that the entire knee pad and support bracket assembly must be removed from the lift when required to do so for exercise. An additional warning statement with diagrams was included in the notice. The accounts were requested to disseminate the information to all users of the affected lifts, to include a copy of the notice in the Instruction for Use Manuals for their lifts, and to complete the Customer Response Form online, using the enclosed card's instructions. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.

Device

  • Modelo / Serial
    Model KKB5060-21US, serial numbers 050186430602,  050186430608, 050186430610, 060186430704, 080186430908, 080186430909, 090186431001, 090186431002, 090186431004, 090186431006, 090186431008, 090186431009, 090186431010,  100186431102, 100186431103, 100186431104, 100186431105, 100186431106, 100186431107, 100186431108, 100186431110, 100186431207, 100186431209, 120186815003, 120186815004,  120186815006, 120186815007, 140186815107, 140186815108, 140186815109, 140186815110, 140186820201, 140186820202, 140186820204, 140186820205, 140186820207, 140186820208,  140186820209, 140186820210, 140186820301, 140186820302, 140186820303, 140186820304, 140186820305, 140186820306, 140186820308, 140186820309, 190084658701, 190084658702,  190084658703, 190084658704, 190084658705, 190084658706, 190084658708, 190084658709, 190084658710, 200084658808, 200084658809, 200084658810, 210084711101, 210084711102,  210084711103, 210084711104, 210084711105, 210084711106, 210084711107, 230084817403, 230084817404, 230084817405, 230084817406, 230084817407, 230084817408, 230084817409,  230084817410, 230084817501, 230084817502, 230084817503, 230084817504, 230084817505, 230084817506, 230084817507, 230084817508, 230084817509, 240084817601, 240084817602,  240084817603, 240084817605, 240084817606, 240084817607, 240084817608, 240084817609, 240084817610, 240084883501, 240084883502, 240084883503, 240084883504, 240084883505,  240084883506, 240084883507, 240084883508, 240084883509, 240084883510, 250084883601, 250084883602, 250084883603, 250084883604, 250084883605, 250084883606, 250084883607,  250084883608, 250084883609, 260084883706, 260084883707, 260084883708, 260084883709, 260084883710, 280084890507, 280084890508, 280084890509, 290085094401, 290085094402, 290085094403, 290085094404, 290085094405, 290085094406, 290085094407, 290085094408, 290085094409, 290085094410, 290085097401, 290085097403, 290085097404, 290085097405,  290085097406, 290085097407, 290085097408, 290085097409, 290085097410, 300085097501, 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510085976704, 510085976705, 510085976707, 510085976708, 510085976710, 520086075301, 520086075302 and 520086075303;  Model KKB5062-21US, serial numbers 010391015510, 020493522101, 020493522102, 020493522103, 020493522104, 020493522105, 020493522106, 030391048708, 030391048709, 040391133401, 040391133402, 040391133403, 040391133404, 040391133408, 040391133409, 050288822704, 050288822705, 050288822706, 050288822708, 050288822709, 050288822710, 050288913701,  050288913702, 050288913703, 050288913704, 050288913705, 050288913706, 050288913707, 050288913708, 050391133508, 050391133509, 050391133510, 050391146201, 050391146202,  050391146203, 050391146204, 050391146205, 050391146206, 060391240510, 060391261107, 060391261108, 060391261110, 070391292701, 080288978202, 080288978203, 080288978204,  080289003502, 080289003503, 080289003504, 080289003505, 080289003506, 080289003507, 080289003508, 080289003509, 080289003510, 090186431007, 090289044001, 090289044009,  090391328804, 090391328805, 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GB080405383T, GB080405384T, GB080405795T, GB080405796T, GB080405797T, GB080405798T, GB090407337T, GB090407338T, GB090407339T, GB100534821T, GB100534822T, GB100534823T, GB120414646T, GB120414647T, GB120414648T, GB120414649T, GB120414650T, GB120414651T, GB120414652T, GB120414653T, GB120539316T, GB120539317T, GB120539318T, GB120539319T, GB120539320T, GB120539321T, GB120539322T, GB170424021T, GB170424022T, GB170424023T, GB170424028T, GB230435450T, GB230435451T, GB250439156T,  GB250439157T, GB250439160T, GB260441754T, GB260441755T, GB260441756T, GB260441758T, GB260441760T, GB260443105T, GB280446487T, GB280446489T, GB280466488T, GB300448385T, GB300448387T, GB300448388T, GB300448389T, GB300448390T, GB370458261T, GB370458262T, GB370458263T, GB370458264T, GB390461960T, GB390461961T, GB390461962T, GB390461963T, GB390461964T, GB390461965T, GB390461966T, GB390461967T, GB390461968T, GB390461969T, GB400465379T, GB400465380T, GB400465381T, GB400465382T, GB400465383T, GB400465384T, GB410467120T, GB410467121T, GB410467123T, GB410467126T, GB450476122T, GB450476123T, GB450476124T, GB450476125T, GB450476126T, GB490408657T, GB490408658T, GB490408659T, GB490408660T, GB490408661T, GB490408662T, GB490408663T, GB490408664T, GB490408665T, GB490408666T and GB490408667T;  and Model KKB5080-21US, serial numbers 010390930401 010390930403, 010390930404, 010390930405, 010390930406, 010390930407, 010390930408, 010390930409, 010390930410, 030391005101, 040391134707, 040391134708, 040391134709, 040391134710, 050391134801, 050391134802, 050391134803, 050391134804, 050391134805, 050391134806, 050391134807, 050391134808, 050391134809, 050391134810, 050391134901,  050391134904, 050391134905, 050391134906, 050391134907, 050391134908, 050391134909, 050391134910, 060391201101, 060391201102, 060391201103, 060391201104, 060391201106,  060391201108, 060391201109, 060391201110, 090391293401, 090391293402, 090391293403, 090391293404, 090391293405, 090391293406, 090391293407, 110391375201, 110391375202, 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400392597404, 400392597405, 400392597406, 400392597407,  400392597408, 400392597409, 420392720703, 420392720704, 420392720705, 420392720706, 420392720707, 420392720708, 420392720709, 420392720710, 430290354803, 430290354804,  430290354805, 430290354806, 430290354808, 430290354809, 430290354810, 430392834701, 430392834702, 430392834703, 430392834704, 430392834708, 430392834709, 430392834710, 450393044601, 450393044602, 450393044603, 450393044604, 450393044605, 450393044606, 450393044607, 450393044608, 450393044609, 450393044610, 450393044701, 450393044705, 450393044710, 460290546201, 460290546202, 460290546203, 460290546204, 460290546205, 460290546206, 460290546207, 460290546208, 460290546209, 460290546210, 460393044801,  460393044802, 460393044803, 460393044804, 460393044806, 460393044808, 460393044809, 460393044810, 470290591901, 470290591902, 470290591903, 470290591904, 470290591905,, 470290591906, 470393044901, 470393044902, 470393044904, 470393044905, 470393044906, 470393044907, 470393044908, 480290819202, 480290819203, 480290819209, 480290819210, 480290832001, 480290832002, 480290832003, 480290832004, 480290832005, 480290832007, 480290832008, 480290832009, 480290832010, 480393045001, 480393045002, 480393045003, 480393045004, 480393045005, 480393045006, 480393045007, 480393045008, 480393045009, 480393045010, 482029083204, 490290832101, 490290832103, 490290832104, 490290832105, 490290832106, 490290832107, 490290832108, 490290832109, 490290832110, 490393069503, 490393069504, 490393069505, 490393069506, 490393069507, 490393069508, 490393069509, 490393069510, 490393099501, 490393099502, 490393099503, 490393099504, 490393099505, 490393099506, 490393099507, 490393099508, 490393099509, 490393099510, 500393118801, 500393118802, 500393118803, 500393118804, 500393118805, 500393118806, 500393118807, 500393118808, 500393118809, 500393118810, 500393118901, 500393118902, 500393118903, 500393118904, 500393118905, 500393118906, 510290832202, 510290832203, 510290832204, 510290832205, 510290832206, 510290832207, 510290832208, 510290832209, 510290832210, 510290889401, 510290889402, 510290889403, 510290889404, 510290889406, 510290889407, 510290889408, 510290889409, 510290899405, GB060402327T, GB060402328T, GB060402329T, GB060402330T, GB060402331T, GB060402332T, GB060402333T, GB110537656T, GB110537657T, GB110537658T, GB110537659T, GB110537660T, GB110537661T, GB110537662T, GB110537663T, GB110537664T, GB110537665T, GB120540046T, GB120540047T, GB120540048T, GB120540049T, GB120540050T, GB120540051T, GB120540052T, GB120540053T, GB120540054T, GB120540055T, GB130417812T, GB130417813T, GB130417814T, GB130417817T, GB130417818T, GB130417819T, GB130417820T, GB130417821T, GB130541300T, GB130541301T, GB130541302T, GB130541303T, GB130541304T, GB130541305T, GB130541306T, GB130541307T, GB150420741T, GB150420742T, GB150420743T, GB150420744T, GB150420745T, GB150420746T, GB150420747T, GB150420748T, GB150420749T, GB150420750T, GB160422810T, GB160422811T, GB160422812T, GB170425490T, GB170425491T, GB170425492T, GB170425494T, GB170425495T, GB170425496T, GB170425497T, GB170425498T, GB170425499T, GB190428732T, GB190428733T, GB190428734T, GB190428735T, GB190428736T, GB190428738T, GB190428739T, GB190428740T, GB190428741T, GB220434081T, GB220434082T, GB220434083T, GB220434084T, GB220434085T, GB220434086T, GB220434087T, GB220434088T, GB220434089T, GB220434090T, GB220434599T, GB220434600T, GB220434601T,  GB220434602T, GB220434603T, GB220434604T, GB220434605T, GB220434606T, GB220434607T, GB220434608T, GB230435903T, GB230435904T, GB230435905T, GB230435906T, GB230435907T, GB230435908T, GB230435909T, GB230435910T, GB230435911T, GB230435912T, GB250440700T, GB250440701T, GB250440702T, GB250440703T, GB250440704T, GB250440705T, GB250440706T, GB250440707T, GB250440708T, GB260441366T, GB260441368T, GB260441369T, GB260441370T, GB260441371T, GB260441372T, GB260441373T, GB260441374T, GB260441375T, GB270444953T, GB270444954T, GB270444955T, GB270444956T, GB270444958T, GB270444959T, GB300448820T, GB300448823T, GB300448824T, GB300448825T, GB300448826T, GB300448827T, GB300448828T, GB300448829T, GB320452306T, GB320452307T, GB320452308T, GB320452309T, GB320452310T, GB320452311T, GB320452312T, GB320452313T, GB320452314T, GB320452315T, GB340454664T, GB340454665T, GB340454666T, GB340454667T, GB340454668T, GB340454671T, GB340454672T, GB340454673T, GB390461245T, GB390461246T, GB390461247T, GB390461248T, GB390461249T, GB390461250T, GB390461251T, GB390461252T, GB390461253T, GB390461254T, GB400464772T, GB400464773T, GB400464774T, GB400464775T, GB400464776T, GB400464777T, GB400464778T, GB400464779T, GB400464780T, GB400464781T, GB410465843T, GB410465844T, GB410465845T, GB410465846T, GB410465847T, GB410465848T, GB410465849T, GB410465850T, GB420468355T, GB420468356T, GB420468357T, GB420468358T, GB420468359T, GB420468360T, GB420468361T, GB420468362T, GB420468363T, GB420468364T, GB420468902T, GB420468903T, GB420468904T, GB420468905T, GB420468906T, GB420468907T, GB420468908T, GB420468909T, GB420468910T, GB420468911T, GB470479419T, GB470479420T, GB470479421T, GB470479422T, GB470479423T, GB470479425T, GB470479426T, GB470479427T, GB480406353T, GB480406354T, GB480406355T, GB480406356T, GB480406357T, GB480406358T, GB480406359T, GB480406360T, GB480406361T, GB480406362T, GB480406744T, GB480406745T, GB480406746T, GB480406747T, GB480406748T, GB480406749T, GB480406750T, GB480406751T, GB480406752T, GB480406753T, GB480407131T, GB480407132T, GB480407133T, GB480407134T, GB480407135T, GB480407136T, GB480407137T, GB480407138T, GB480407139T, GB480407140T, GB480407350T, GB480407351T, GB480407352T, GB480407353T, GB480407354T, GB480407355T, GB480407356T, GB480407357T, GB480407358T, GB480407359T, GB490408079T, GB490408080T, GB490408081T, GB490408082T, GB490408083T, GB490408084T, GB490408085T, GB490408086T, GB490408087T, GB490408088T, GB520413764T, GB520413765T, GB520413766T, GB520413767T, GB520413768T, GB520413769T, GB520413770T, GB520413771T, GB520413772T, GB520413773T, GB520414012T, GB520414013T, GB520414014T, GB520414015T, GB520414016T, GB520414017T, GB520414018T, GB520414019T and GB520414020T,
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
  • Descripción del producto
    Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. || The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA