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.
Reported: June 25, 2014 Initiated: May 29, 2014 #Z-1807-2014
Product Description
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.
Reason for Recall
A bug in the software prevents the iGUIDE software from logging off.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 224
- Distribution
- 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
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Elekta, Inc.. Units affected: 224.
Why was this product recalled? ▼
A bug in the software prevents the iGUIDE software from logging off.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1807-2014.
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