FDAFDA · Alimentos y medicamentos·N.º oficial Z-1753-2013
Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
Publicado el 24 de julio de 2013 · Inicio del retiro: 25 de abril de 2013
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
A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is three times the Maximum Fluoro Dose limit of 10 R/min.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Leibel-Flarsheim Company LLC
- Distribuidor
- Nationwide Distribution (US), including the states of TN, KY, CO, KS, CT, HI, and AZ.
- Lote
- The following catalog numbers, serial numbers and associated manufacturing dates are affected by this recall: 700539 CI0807H273 August2007; 700539 CI0106H162 January 2006; 700539 CI1010H523 October 2010; 700539 CI0811H567 August 2011; 700539 CI0108H313 January 2008; 700539 CI0309H418 March 2009; 700539 15031229 Apri12003; 700539 14031227 Apri12003; 700539 CI0404H045 January 2005; 700539 CI0504H054 May 2004; 700539 CI1106H208 November 2006; 700539 CI0509H424 May 2009
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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