U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Lift, patient, non-ac-powered - Product Code FSA
원인
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.
조치
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.
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.
제품 설명
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.