Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1697-2011

Liko Capella 201 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for...

Hill-Rom Inc. / initiated 2011-01-27 / Terminated / root cause: design

Hill-Rom, Inc. began a recall of Liko Capella 201 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1697-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Liko Capella 201 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
Product code
FSA Lift, Patient, Non-Ac-Powered
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.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
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, WA, WI, and WV; and country of: Canada.
Product codes and lots
All lifts from 1997 to the present.