Recall Z-0872-2013
Hill-Rom, Inc. · initiated October 31, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
Codes / lots: The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.
Reason for recall
Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have fallen down while in use in high humidity (swimming pool) areas. Analysis of the incidents suggest that the components (hardware) used to secure the rail to the ceiling had corroded and may be unsuitable for environments with an atmosphere con
FDA-determined cause: Device Design
Action taken
Liko, a Hill-Rom company, sent an URGENT MEDICAL DEVICE RECALL notice dated October 31, 2012 to all affected customers. Letter identified the affected product, problem and actions to be taken until a new design is finalized and the field corrective action implemented. The letter instructed customers to complete and return the Response Form immediately even if you do not have any rail systems in a chlorinated environment. For questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720.
Details
- Recall number
- Z-0872-2013
- Initiated
- October 31, 2012
- Posted by FDA
- February 21, 2013
- Terminated
- March 9, 2016
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Quantity
- 3816 in total
- Distribution
- Worldwide Distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and CANADA LOCATIONS: AB, BC, MB, NB, NS, ON, and SK.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN