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Recall Observatory FDA recall evidence

Device product

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

Z-1818-2015

March 20, 2015

Class II

Product summary

Firm
Hill-Rom, Inc.
Event
Event 71132
Status
Terminated
Classification
Class II
Quantity
24, 798
Official record key
device-enforcement:Z-1818-2015

Official wording

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 information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.