FDAFDA · Alimentos y medicamentos·N.º oficial Z-2349-2018
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
Publicado el 11 de julio de 2018 · Inicio del retiro: 10 de mayo de 2018
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
The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- FHC, Inc.
- Distribuidor
- The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
- Lote
- UDI: 00873263004418
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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