BEUDAMED
    FDA Enforcement Class II Terminated

    Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.

    Recall: Z-1818-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1818-2015
    Event ID
    71132
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    June 24, 2015
    Initiation Date
    March 20, 2015
    Classification Date
    June 18, 2015
    Termination Date
    August 4, 2017
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520, United States

    Description

    Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.

    Reason

    Complaints (including one reported death) allegedly of the lift arm drifting down suddenly. If the lift arm assembly is manually lifted, the actuator can become damaged and get stuck in the highest position. If a patient is lifted into the sling while the actuator is stuck, there is a potential risk of a free fall of the patient, resulting in minor or potentially catastrophic injuries.

    Code Info

    Viking¿ M Lift  Model 2040035 (S/N 9 200 000 - 9 201 689)  Model 2040015 (S/N 7 500 401 - 7 568 899)  Model 2040005 (S/N 7 100 101 - 7 200 200) Viking¿ L Lift  Model 2040004 (S/N 7 200 201 - 7 300 300) Viking¿ XL/Viking¿ 300 Lift  Model 2040003 (S/N 800 001 - 804 999)

    Distribution

    Worldwide Distribution -- AE, AO, AR, AT, AU, AZ, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CS, CZ, DE, DK, EG, ES, FI, FR, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LI, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, SY, TH, TN, TR, TW, UK, US, VE, and ZA.

    Quantity

    24, 798