Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Overhead Rail System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Overhead Rail System see related information
Date Initiated by Firm October 31, 2012
Date Posted February 21, 2013
Recall Status1 Terminated 3 on March 09, 2016
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 IN 47006-7520
For Additional Information Contact
812-934-7777
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		 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 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.
-
-