Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people wh

FDA device recall Z-1695-2011 · posted 2011-03-17 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

Reason for recall

The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports, two were injuries in patients during use and four injuries were in non-patients when they tripped over the lift device and fell on the unit.

Action taken

The firm, Liko, issued two "URGENT FIELD SAFETY NOTICES" one dated January 27, 2011 and a follow-up notice dated February 9, 2011 to its consignees/customers. The notices described the product, problem and actions to be taken. The customers were instructed to keep the device in a separate unoccupied area when not in use; use extra care and support when lifting patients with the device; not allow unauthorized persons, especially children, to play around or operate the lift; examine the sling hooks daily to make sure they are secure, and to forward a copy of this notice to any other facility personnel they deem appropriate. The notices state the firm is investigating a design change to mitigate the risk of injuries with the device. If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

1,009 all products

Distribution

Worldwide distribution: USA including: AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK ,OR, PA, RI, SC, SD, TN ,TX, UT, VA, W

Date initiated

2011-01-27

Date posted

2011-03-17

Date terminated

2014-09-19

Location

Batesville, IN