FDAFDA · Alimentos y medicamentos·N.º oficial Z-0171-2014
Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.
Publicado el 13 de noviembre de 2013 · Inicio del retiro: 29 de noviembre 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
Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Handicare Accessibility
- Distribuidor
- Worldwide distribution: USA (Nationwide) and country of: Canada.
- Lote
- Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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