FDA Enforcement Class II Terminated

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.

Recall: Z-0872-2013 · Reported February 27, 2013

Enforcement

Recall Number
Z-0872-2013
Event ID
62334
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Hill-Rom, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
February 27, 2013
Initiation Date
October 31, 2012
Classification Date
February 21, 2013
Termination Date
March 9, 2016
Address
1069 State Route 46 East, N/A, Batesville, IN, 47006-7520, United States

Description

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.

Reason

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

Code Info

The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.

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.

Quantity

3816 in total