Device product
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
Z-1064-2014
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 65450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 449
- Official record key
device-enforcement:Z-1064-2014
Official wording
Reason: Customers are resetting the default values outside recommended factory settings.
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Distribution pattern: Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
Derived failure modes
-
Unknown
Customers are resetting the default values outside recommended factory settings.