Class 2 Device Recall Chorus Mobile Patient Lifter

• Date Initiated by Firm: June 29, 2012
• Date Posted: July 06, 2012
• Recall Status: Terminated on March 13, 2018
• Recall Number: Z-1948-2012
• Recall Event ID: 62116
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: 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.
• 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, 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510085976702, 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, 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500188537403, 500188537404, 500188537405, 500188537406, 500188537407, 500188537408, 500188537409, 500188537410, 500290831504, 500290831505, 500290831506, 500290831507, 500290831508, 500290831509, 500290831510, 500290831601, 500290831602, 500290831603, 500290831604, 500290831605, 500290831606, 500290831607, 500290831608, 510085976604, 510188636401, 510188636402, 510188636403, 510188636404, 510188636405, 510188636406, 510188636407, 510188636408, 510188636409, 510188636410, 510188669901, 510290870101, 510290870104, 510290870105, 510290870106, 510290870107, 510290877503, 510290877504, 510290877505, 510290877506, 510290877507, 510290877508, 510393181203, 510393181204, 510393181205, 510393181206, 530290929802, 530290929803, 530290929804, 530290929805, 530290929806, 530290929807, 530290929808, 530290929809, 530290929810, 530393461707, 530393461708, 530393461709, 530393461710, 530393490701, 530393490702, 530393490703, 530393490704, 630391261106, GB060402522T, GB060402523T, GB080405381T, 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• Recalling Firm/ Manufacturer: Arjo, Inc. dba ArjoHuntleigh; 2349 W Lake St; Addison IL 60101-6183
• For Additional Information Contact: 800-323-1245
• Manufacturer 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.
• FDA Determined Cause: Labeling False and Misleading
• 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.
• Quantity in Commerce: 1,989 units in the U.S., 1,626 units in the rest of the world
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.