Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Enforcement
- Recall Number
- Z-1322-2014
- Event ID
- 67574
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Elekta, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 9, 2014
- Initiation Date
- March 28, 2013
- Classification Date
- April 2, 2014
- Termination Date
- July 26, 2017
- Address
- 400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227, United States
Description
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
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Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CT, FL, GA, KY, LA, MD, MO, NM, NY, NC, OH, OK, PA, TN, TX, and WA and the countries of Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Romania, Russia, Saudi Arabia, Senegal, Singapore, Slovakia, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
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