Class 2 Device Recall HillRom Liko

• Date Initiated by Firm: March 20, 2015
• Date Posted: June 19, 2015
• Recall Status: Terminated on August 04, 2017
• Recall Number: Z-1818-2015
• Recall Event ID: 71132
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
• 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)
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 1069 State Road 46 E; Batesville IN 47006-7520
• For Additional Information Contact: 800-445-3720
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling design
• Action: On 3/20/2015, URGENT Field Safety Notice notifications, dated 3/19/2015 were sent to US customers by e-mail and or courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are forward a copy of the letter to any other appropriate facility personnel. Additionally, the attached form should be completed and returned to Hill-Rom. Upon receipt, the firm will contact customers to schedule an inspection of the potentially affected devices. For questions, call 800-445-3720 (Mon - Thurs, 8 am - 6:30 pm; Friday, 8 am - 6 pm).
• Quantity in Commerce: 24, 798
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.