Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0872-2013 | Class II | Terminated | Voluntary: Firm initiated |
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