Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2S...
FDA Device Recall #Z-1948-2012 — Class II — June 29, 2012
Recall Summary
| Recall Number | Z-1948-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 29, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arjo, Inc. dba ArjoHuntleigh |
| Location | Addison, IL |
| Product Type | Devices |
| Quantity | 1,989 units in the U.S., 1,626 units in the rest of the world |
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.
Reason for Recall
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.
Distribution Pattern
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
Lot / Code Information
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, 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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, 090391328806, 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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, 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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,
Other Recalls from Arjo, Inc. dba ArjoHuntleigh
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2714-2017 | Class II | ArjoHuntleigh Flowtron ACS900, medical pump, so... | Jun 14, 2017 |
| Z-1388-2016 | Class II | The Concerto Basic Shower Trolley is intended f... | Dec 21, 2015 |
| Z-0079-2015 | Class II | Medium 2-Hooks Spreader Bar for use with Loop S... | Jan 21, 2013 |
| Z-0615-2013 | Class II | Flowtron Trio DVT Pump; an Rx intermittent pneu... | Dec 10, 2012 |
| Z-0476-2013 | Class II | Enterprise 8000 Bed; an AC-powered adjustable h... | Nov 16, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.