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

FDA device recall Z-1818-2015 · posted 2015-06-19 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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.

Action taken

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).

Root cause

Labeling design

Status

Terminated

Product code

FSA

Quantity affected

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

Date initiated

2015-03-20

Date posted

2015-06-19

Date terminated

2017-08-04

Location

Batesville, IN