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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0872-2013

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.

Publicado el 27 de febrero de 2013 · Inicio del retiro: 31 de octubre de 2012

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Hill-Rom, Inc.
Distribuidor
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.
Lote
The Liko Overhead Rail System components are not serialized and have been distributed since the early 1980's to the present.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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