Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0872-2013Class II

Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall...

Hill-Rom Inc. / initiated 2012-10-31 / Terminated / root cause: design

Hill-Rom, Inc. began a recall of Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The... on . FDA classified it as Class II and gives the reason as "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)...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0872-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
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.
Product code
FSA Lift, Patient, Non-Ac-Powered
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
Root cause tag
design
FDA root cause
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.
Product codes and lots
The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0872-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0872-2013Class IITerminatedVoluntary: Firm initiated