Recall Z-1693-2011
Hill-Rom, Inc. · initiated January 27, 2011
Product
Liko Sabina EM 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.
Codes / lots: All lifts from 1997 to the present.
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 patints during use and four injuries were in non-patients when they tripped over the lift device and fell on the unit.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1693-2011
- Initiated
- January 27, 2011
- Posted by FDA
- March 17, 2011
- Terminated
- September 19, 2014
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Quantity
- 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.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1691-2011 | Liko Sabina EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1692-2011 | Liko Sabina II EE Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1694-2011 | Liko Sabina II EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1695-2011 | Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1696-2011 | Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |
| Z-1697-2011 | Liko Capella 201 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are…The firm has received reports of injuries related to the Sabina Sit-in-Stand lifts. Of six injury reports… | 01/27/2011Terminated |