Recall of Device Recall Chorus Mobile Patient Lifter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arjo, Inc. dba ArjoHuntleigh.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62116
  • Event Risk Class
    Class 2
  • Event Number
    Z-1948-2012
  • Event Initiated Date
    2012-06-29
  • Event Date Posted
    2012-07-06
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2018-03-13
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    Lift, patient, non-ac-powered - Product Code FSA
  • Reason
    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.
  • Action
    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

  • Model / 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,  110391375203, 110391375204, 110391375205, 110391375206, 110391375207, 110391375208, 110391375209, 110391375210, 130289044105, 130289044106, 130289044107, 130289044108,  130289044109, 130289044110, 150289328101, 150289328102, 150289328103, 150289328104, 150289328105, 150289328107, 150289328108, 150289328109, 150289328110, 150391568501,  150391568502, 150391568503, 150391568504, 150391568505, 150391568506, 150391568507, 150391568508, 150391568509, 150391568510, 160289328209, 160289328210, 160391682201,  160391682202, 160391682203, 160391682204, 160391682205, 160391682206, 160391682207, 160391682208, 160391682209, 160391682210, 170289431501, 170289431502, 170289431503,  170289431504, 170289431505, 170289431506, 170289431508, 170289431509, 170289431510, 180391707501, 180391707502, 180391707503, 180391707504, 180391707505, 180391707506,  180391707507, 180391707508, 200289620801, 200289620802, 200289620803, 200289620804, 200289620805, 200289620806, 200289620808, 200289620809, 200289620810, 200289620901,  200289620902, 200289620903, 200289620904, 200289620905, 200289620906, 200289620907, 200289620908, 200289620910, 200289621001, 200289621002, 200289621003, 200289621004,  200289621005, 200289621006, 200289621007, 200289621008, 200289621009, 200289621010, 200289621101, 200289621102, 200289621103, 200289621104, 200289621105, 200289621106, 200289621107, 200289621108, 200289621109, 200289621110, 200391940410, 202896208007, 210370000002, 210391967101, 210391967102, 210391967103, 210391967104, 210391967105, 210391967106, 210391967107, 210391967108, 210391967109, 220391858001, 220391858002, 220391858003, 220391858004, 220391858005, 220391875701, 220391875702, 220391875703, 220391875704, 230392039101, 230392039102, 230392039103, 230392039104, 230392039105, 230392039106, 230392039107, 230392039108, 230392039109, 230392039110, 240289716501, 240289716502, 240289716505, 240289716506, 240289716507, 240289716508, 240289716509, 240392039201, 240392039202, 240392039203, 240392039204, 240392039205, 240392039206,  240392039207, 240392039208, 240392039209, 240392039210, 250392039301, 250392039302, 250392039303, 250392039304, 280392230401, 280392230402, 280392230403, 280392230404,  280392230405, 280392230406, 280392230407, 280392230408, 280392230409, 280392230410, 280392230501, 280392230502, 280392230503, 280392230504, 280392230505, 280392230506,  280392230507, 280392230508, 280392230509, 280392230510, 280392230601, 280392230602, 280392230603, 280392230604, 280392230605, 280392230606, 280392230607, 280392230608, 280392230609, 280392230610, 290392230701, 290392230702, 290392230703, 290392230704, 290392230705, 290392230706, 290392230707, 290392230708, 290392230709, 290392230710,  290392230801, 290392230802, 290392230803, 290392230804, 290392230805, 290392230806, 290392230807, 290392230808, 290392230809, 290392230810, 300392275901, 300392275902,  300392275903, 300392275904, 300392275905, 300392275906, 300392275907, 300392275908, 300392275909, 300392275910, 310392300901, 310392300902, 310392300903, 310392300904,  310392300906, 310392300907, 310392300908, 310392300909, 310392300910, 310392349001, 310392349002, 310392349003, 310392349004, 310392349005, 310392349006, 310392349007,  310392349008, 310392349009, 310392349010, 320392349101, 320392349102, 320392349103, 320392349104, 320392349105, 320392349106, 320392349107, 320392349108, 320392349109,  320392349110, 330392405503, 330392405504, 330392405505, 330392405506, 330392405507, 330392405508, 330392405509, 330392405510, 340392300905, 370290170403, 370290170404,  370290170405, 370290170406, 370290170407, 370392555201, 370392555202, 370392555203, 370392555204, 370392555205, 370392555206, 370392555207, 370392555208, 370392555209,  370392555210, 390290276903, 390290276904, 390290276905, 390290276906, 390290276907, 390290276908, 390290276909, 390290276910, 400290311501, 400290311502, 400290311503, 400290311504, 400290311505, 400290311506, 400290311507, 400290311508, 400392597401, 400392597402, 400392597403, 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,
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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

  • Manufacturer Address
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Manufacturer Parent Company (2017)
  • Source
    USFDA