FDAFDA · Alimentos y medicamentos·N.º oficial Z-1817-2012
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Publicado el 27 de junio de 2012 · Inicio del retiro: 22 de febrero 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
Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- American Optisurgical Inc
- Distribuidor
- Nationwide distribution: MN only.
- Lote
- Product Codes: LFL, GEI, Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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