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U.S. Department of Health and Human Services

Class 2 Device Recall Liko Sabina II EE Lift

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  Class 2 Device Recall Liko Sabina II EE Lift see related information
Date Initiated by Firm January 27, 2011
Date Posted March 17, 2011
Recall Status1 Terminated 3 on September 19, 2014
Recall Number Z-1692-2011
Recall Event ID 57734
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product Liko Sabina II EE 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.
Code Information All lifts from 1997 to the present.
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006
For Additional Information Contact
812-934-7777
Manufacturer 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 2		 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.
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.
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.
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