Events

Recall of Device Recall Getinge 46Series Medical WasherDisinfector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Getinge Disinfection Ab.

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
    69823
  • Event Risk Class
    Class 2
  • Event Number
    Z-0852-2015
  • Event Initiated Date
    2014-11-26
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131600
  • 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
    Disinfector, medical devices - Product Code MEC
  • Reason
    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.
  • 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.

Device

Device Recall Getinge 46Series Medical WasherDisinfector
  • Model / Serial
    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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the country of Canada.
  • Product Description
    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.
  • Manufacturer
    Getinge Disinfection Ab

Manufacturer

Getinge Disinfection Ab
  • Manufacturer Address
    Getinge Disinfection Ab, Ljungadalsgatan 11, Vaxjo Sweden
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA