Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Recall Z-1561-2016 · Posted None
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIWB
Date Initiated2016-04-19
Date Terminated2021-07-16
Product Quantity217
Reason for Recall
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
Firm Action
Elekta sent an Important User Notice (100-03-202-27) letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement Form attached. For questions contact your local Elekta office.
Root Cause
Use error
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MI, MN, MS, MO, MT, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WV, WI, and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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