BEUDAMED
    FDA Recall Open, Classified

    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift

    Recall: Z-0681-2022 · Initiated April 20, 2016

    Recall

    Recall Number
    Z-0681-2022
    Event Number
    88610
    Firm
    Acorn Stairlifts, Inc
    FEI Number
    3003124453
    Product Code
    PCD
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    April 20, 2016
    Address
    7001 Lake Ellenor Dr, Belle Isle, FL, 32809-5701

    Description

    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift

    Reason

    The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.

    Action

    A Recall notification letter titled, "URGENT-MEDICAL DEVICE RECALL" was sent via mail to The recalling firm began notifying direct consumers of the recall via telephone on 4/20/2016. The phone script asked them to confirm the stairlift is still installed at their address and that as a precautionary measure, they are going to replace one of the components on the stairlift. The customer was asked when an appointment could be made. If the customer no longer had the lift installed at their address, they were asked for details on its disposition. No additional details were given to the customer regarding the specific issue or hazard involved. If the direct consumers were unable to be reached via telephone, they were mailed an undated "IMPORTANT RECALL SAFETY NOTICE. ACTION REQUIRED!" It said the safety of their customers is always of paramount importance, therefore, they are to contact the firm. A toll-free telephone number was provided as well as an email address. The reason for recall was explained that one of the stairlift components needs to be replaced and the seat base could weaken over time causing a remote possibility the seat base could crack or separate from the seat assembly. The telephone number was again provided. If the firm is still unable to get a response from the customer, a company field technical would visit the residence to offer to replace the seat in person. If no one was home, a door tag would be left which requests the customer to contact them, and the phone number and email address is provided. The tag also asks if the customer still has the stairlift and if it is no longer there, they would like to know its disposition. The firm issued letters dated 8/6/2021 to distributors via mail on 8/10/2021. The letter explained the issue with seats used in some of the motorized stairlifts. The distributor was instructed to replace existing seats with a replacement seat within 60 days of the date of the letter. If the distributor wa

    Distribution

    Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, and WY, as well as Puerto Rico and the Virgin Islands. There was no foreign/military/government distribution.

    Quantity

    26,428