BEUDAMED
    FDA Recall Terminated

    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

    Recall: Z-0783-2022 · Initiated January 14, 2022

    Recall

    Recall Number
    Z-0783-2022
    Event Number
    89562
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 14, 2022
    Terminated
    November 7, 2024
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    Description

    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

    Reason

    Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients

    Action

    HillRom issued Urgent Medical Device Correction letter(FA-2021-11-004-LUL-002) on the 14th of January via UPS Ground service. Letter states reason for recall, health risk and action to take: Actions to be taken by Customer: Please identify if you have the potentially affected product in your facility (See affected device listing above). Do not use your traverse carrier until inspected by a Hillrom Technician. Return the response form below within two weeks. Upon receipt of the response form, Hillrom will contact you to schedule a visit to inspect your carriers. Should incorrect, non-conforming screws be present, these will be exchanged by an approved Hillrom technician. Action to be taken by the Distributor: Please share this Field Safety Notice with your end users and complete the attached response form and return to [email protected] within two weeks. Hillrom will provide replacement screws for Distributors to facilitate exchange among your end users. Action to be taken by Hillrom: Hillrom will arrange a site visit to inspect the potentially affected units. If short screws are identified, they will be exchanged with those of correct length. Contact reference person If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or [email protected] .

    Distribution

    Worldwide distribution - US Nationwide and the countries of AT, CA, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IT, JP, NL, NO, NZ, RU, SE, SG, SK.

    Quantity

    Traverse Rail Carrier E-System, wide 31017XX 5 Traverse Rail Carrier 31025XX 1798