BEUDAMED
    FDA Recall Open, Classified

    Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.

    Recall: Z-1078-2022 · Initiated April 1, 2022

    Recall

    Recall Number
    Z-1078-2022
    Event Number
    89998
    Firm
    Getinge Usa Sales Inc
    FEI Number
    3013876692
    Product Code
    MEC
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    April 1, 2022
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035

    Description

    Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.

    Reason

    Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.

    Action

    An Urgent Medical Device Notification was issued 04/01/2022 via FedEx which includes serial numbers for affected devices. Customers are to verify they have an affected device and submit the attached Response Form. Distributors are to forward notification on to customers. Getinge service technicians will contact customers to schedule corrective actions. You can continue to use the Getinge Series 9100E-series Washer Disinfector with G1 control systems until the corrective action is performed, there are no precautionary actions necessary. Contact your Getinge representative with questions or for Technical Support call (888) 943-8872 (options 4,2,1), Monday through Friday, 8:00 a.m. - 6:00 p.m EST, or email [email protected].

    Distribution

    Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    127