Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Reported: March 12, 2014 Initiated: November 25, 2013 #Z-1085-2014
Product Description
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Reason for Recall
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 134
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.. Recalled by Elekta, Inc.. Units affected: 134.
Why was this product recalled? ▼
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 12, 2014. Severity: Moderate. Recall number: Z-1085-2014.
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