Class 2 Device Recall Getinge 46Series Medical WasherDisinfector

• Date Initiated by Firm: November 26, 2014
• Date Posted: December 23, 2014
• Recall Status: Terminated on May 12, 2017
• Recall Number: Z-0852-2015
• Recall Event ID: 69823
• Product Classification: Disinfector, medical devices - Product Code MEC
• Product: GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
• Code Information: Serial Numbers: SEV0810077, SEV0537108, SEV0633084, W50030454, SEV0724143, SEV0724146, SEV0609110, W50044787, SEV0533068, W50042461, W50023731, W50023732, W50038744, W50028760, SEV0802081, W50015468, W50042473, W50045852, W50048201, W50041156, SEV0911139, SEV0832021, W50031347, SEV0538174, SEV0910190, SEV0734181, W50033518, SEV0802083, W50043877, W50015494, W50047828, SEV0633086, SEV0647025, SEV0650003, SEV0650004, SEV0534069, SEV0617130, W50011492, SEV0538177, W50010176, W50027826, SEV0743108, W50012356, SEV0614021, W50039525, SEV0619121, W50021052, W50025573, W50024233, W50010768, SEV0827061, SEV0738121, SEV0804079, SEV0806117, SEV0820063, SEV0820064, W50041988, SEV0727015, SEV0739202, SEV0906031, SEV0814068, SEV0805187, W50050381, W50050415, SEV0808424, SEV0626127, SEV0645102, SEV0710062, SEV0802086, SEV0815031, SEV0815032, W50027223, W50027224, SEV0826158, W50027541, W50043237, SEV0906032, W50012254, W50038229, W50014011, W50013832, W50012253, W50036280, W50036309, W50048577, SEV0537107, SEV0842075, SEV0750143, W50016365, SEV0808427, SEV0724139, SEV0724145, W50038722, SEV0908129, SEV0908130, SEV0649007, W50023502, SEV0842076, SEV0808429, SEV0837132, SEV0827051, W50027618, SEV0705085, SEV0705084, SEV0705083, W50026375, W50023804, W50014025, SEV0742115, W50028434, W50040964, W50019155, W50010908, W50013646, W50036143, W50045596, W50029312, W50029313, SEV0806118, W50028808, W50045860, W50014993, SEV0636055, SEV0738120, W50050491, W50028245, W50035227, W50048232, SEV0626230, W50023210, W50030137, SEV0808430, SEV0724144, SEV0534064, WAA053021, W50041067, W50030350, SEV0540080, W50045855, W50032192, W50029835, W50031507, SEV0739208, SEV0802085, SEV0622093, SEV0650002, SEV0619122, W50016086, W50039500, SEV0543058, SEV0910191, SEV0837135, W50018212, SEV0537103, WAA052845, SEV0605066, W50034170, SEV0524337, W50011160, W50011491, W50032801, W50015395, W50042391, SEV0547204, W50045890, W50047809, W50013644, W50013645, W50030121, W50021208, SEV0626228, SEV0851034, SEV0827047, SEV0552041, W50037851, SEV0833107, SEV0833108, SEV0833109, SEV0833110, SEV0833111, W50036056, W50036081, SEV0837131, W50015490, SEV0716176, SEV0716177, W50043774, W50023888, SEV0738132, SEV0827050, SEV0724140, W50015641, W50045601, W50024979, SEV0614035, W50016223, W50025076, SEV0815030, SEV0820065, W50016368, SEV0647023, SEV0909043, W50037190, SEV0642143, W50017770, SEV0537110, SEV0543054, SEV0538178, W50023488, SEV0614036, SEV0614037, SEV0533067, W50029860, W50029036, SEV0814067, SEV0851035, SEV0851036, W50013647, SEV0738001, SEV0739204, SEV0810081, SEV0533069, W50016222, SEV0906030, W50014012, W50019465, W50038218, SEV0521190, W50038730, SEV0826159, W50012251, SEV0738133, SEV0619119, SEV0649010, SEV0619120, SEV0614022, W50050577, W50041166, W50048183, W50017921, SEV0739205, SEV0749123, W50042459, SEV0524338, SEV0820049, SEV0640030, W50030144, W50030181, W50028247, W50014027, W50032581, W50013666, W50042946, W50045884, W50050574, W50013831, SEV0618050, SEV0618051, SEV0727034, SEV0534074, SEV0716188, W50010079, W50033538, W50047210, W50019156, W50032618, W50015495, W50036207, SEV0733024, W50021211, SEV0827056, W50043040, W50028248, W50028468, SEV0605063, SEV0815025, SEV0824064, SEV0808426, W50036147, W50017918, W50018215, W50030353, W50036140, WAA053036, SEV0724142, SEV0533065, W50035801, SEV0907057, W50045822, SEV0836007, W50028320, W50010906, W50028809, W50023209, W50048247, W50027514, SEV0739206, SEV0739209, SEV0626231, SEV0738131, W50038686, W50011489, W50011490, W50046986, SEV0633083, W50021142, SEV0907054, W50021143, SEV0716048, W50023897, SEV0907055, W50011159, SEV0647022, SEV0851037, SEV0907056, W50021141, SEV0826157, SEV0848144, SEV0621158, W50047960, SEV0633088, SEV0705086, SEV0727019, SEV0626121, SEV0626229, W50010177, SEV0738122, SEV0738123, SEV0521184, W50016376, SEV0633087, W50019467, W50015466, W50017920, W50033104, W50025852, W50016366, SEV0632078, SEV0543059, W50048551, W50035559, SEV0521191, SEV0515157, SEV0515159, SEV0548037, SEV0644133, SEV0727032, SEV0820048, SEV0844215, SEV0906028, SEV0906029, W50010905, W50015493, W50037099, W50037204, W50039512, W50042471, W50042478, W50050571, W50050573, W50050578, WAA053175, SEV0618048, SEV0545170, SEV0724147, SEV0632079, SEV0827060, SEV0743107, SEV0820057, SEV0826160, W50029023, SEV0524334, W50011161, W50022983, W50045665, W50048002, W50012252, W50018216, W50018928, W50019154, SEV0734183, W50050575, SEV0820050, W50027512, SEV0716185, SEV0820058, W50041125, SEV0605064, SEV0615074, SEV0649008, SEV0622094, W50016364, SEV0737120, W50038421, SEV0824063, W50017919, SEV0815033, W50033839, SEV0626126, SEV0808428, W50015496, SEV0533071, W50023733, SEV0716184, SEV0742118, SEV0727033, SEV0649009, SEV0810078, W50039166, SEV0618049, W50038256, SEV0536194, SEV0716183, SEV0613001, W50042222, W50043233, SEV0636042, SEV0636043, W50039286, W50017771, SEV0804077, SEV0633085, W50021356, W50021357, SEV0532062, W50020918, W50030145, W50038244, W50036145, SEV0626120, SEV0716175, W50023501, SEV0733032, SEV0734182, SEV0738002, W50010907, W50037207, SEV0708018, W50048219, W50014030, SEV0626234, SEV0738130, W50042491, SEV0543056, SEV0536195, SEV0543055, W50013311, W50028993, SEV0739203, SEV0613098, SEV0739207, SEV0647024, W50035975, SEV0708019, SEV0702017, SEV0805191, SEV0521192, SEV0910192, W50041173, SEV0842074, W50021214, SEV0723112, W50037115, SEV0833100, SEV0833101, SEV0833102, SEV0833103, SEV0833104, W50017914, W50024126, W50029644, SEV0637017, SEV0605065, SEV0724138, W50037201, SEV0536197, W50045549, W50048239, W50011158, SEV0834133, SEV0708020, SEV0710061, SEV0849100, W50017917, W50030122, W50023198, W50018213, W50018214, SEV0533070, SEV0612048, SEV0632080, SEV0727018, SEV0537104, SEV0524333, W50024980, SEV0808423, SEV0734180, W50024130, W50024131, SEV0626125, W50035799, W50015488, SEV0827046, SEV0613100, SEV0615042, SEV0637018, SEV0543057, SEV0810080, W50021145, SEV0548036, SEV0606022, W50028246, W50028112, W50028113, W50027222, W50033877, SEV0908131, W50029035, SEV0827045, W50024981, SEV0521186, SEV0538173, SEV0827057, W50013312, SEV0626232, SEV0613099, W50016367, SEV0626233, W50018929, SEV0911140, SEV0911141, W50015398, SEV0521187, W50041062, SEV0524327, WAA052236, SEV0910189, W50021210, W50030183, SEV0804078, SEV0808425, SEV0626119, SEV0724141, W50047838, W50015491, SEV0643166, SEV0802082 --- Canadian Units: SEV0538175, SEV0613101, W50030182, W50030412.
• Recalling Firm/ Manufacturer: Getinge Disinfection Ab; Ljungadalsgatan 11; Vaxjo Sweden
• For Additional Information Contact: Ms. Ann G. Wheeler; 585-272-5036
• Manufacturer Reason for Recall: Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
• FDA Determined Cause: Device Design
• Action: An Urgent Field Safety Notice was sent to consignees in North America via USPS Certified Mail with signature receipt on 11/25/14 informing them of the correction. The actions that will be carried out will fully address the problem of sedimentation i.e. stop any future sedimentation. You will be contacted by a Getinge representative to schedule a visit. No additional precautions need to be taken by the end user until the Getinge representative arrives. For questions, please contact Getinge USA at 1-800-320-3532.
• Quantity in Commerce: 551 total: USA: 547 units, Canada: 4 units
• Distribution: Distributed US (nationwide) and the country of Canada.
• 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.