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U.S. Department of Health and Human Services

Class 2 Device Recall Overhead Rail System

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 Class 2 Recall
Overhead Rail System
see related information
Date Posted February 21, 2013
Recall Status1 Open
Recall Number Z-0872-2013
Recall Event ID 62334
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
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.
Code Information The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
1069 State Route 46 East
Batesville, Indiana 47006-7520
Consumer Instructions No consumer action necessary
Manufacturer 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 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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