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.
This recall has been terminated (originally issued December 23, 2014).
- Recall Initiated
- November 26, 2014
- Posted
- December 23, 2014
- Terminated
- May 12, 2017
- Recall Number
- Z-0852-2015
- Quantity
- 551 total: USA: 547 units, Canada: 4 units
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed US (nationwide) and the country of Canada.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.