FDAFDA · Food and drugs·Recall number Z-1807-2014
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Published June 25, 2014 · Recall initiated: May 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A bug in the software prevents the iGUIDE software from logging off.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam
- Lot
- Software Versions 2.0.0, 2.0.1 and 2.0.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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