FDAFDA · Alimentos y medicamentos·N.º oficial Z-2737-2020
Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
Publicado el 5 de agosto de 2020 · Inicio del retiro: 30 de junio de 2020
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
Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hill-Rom, Inc.
- Distribuidor
- Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.
- Lote
- Serial Numbers Affected: V133AW9885 through V142AW0261and manufactured between May 12, 2020 and May 21, 2020
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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