Device Recall PercuNav MP008RB Button Probe

  • Modelo / Serial
    Lot codes and Expiry Date: I280903 (09-2012); C151005 (03-2013); E111003 (05-2013); and E251002 (05-2013).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: in the states of FL, IL, MA, NE, NY, SC, and VA. There are no foreign consignees and US government consignees.
  • Descripción del producto
    The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical applications of the Button Probe require sterility and others may not. However, it is possible that patient contamination could occur if a non-sterile Button Probe is used in clinical applications where aseptic technique is required. || The device's labeled in part: " TRAXTAL PERCUNAV...(1) Button Probe Right hand version, 25mm...Traxtal Inc...49 Spadina Avenue, Suite 310 Toronto, ON Canada M5V 2J1...Made In Canada...www.traxtal.com...STERILE...For use with Traxtal's PercuNav system only. Do not use if package is opened or damaged. Dispose of safely after single use to avoid risk of infection...Rx only...Use immediately after opening unit package. Store at room temperature".
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA