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Recall Observatory FDA recall evidence

Device product

Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Z-1061-2014

November 25, 2013

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 67230
Status
Terminated
Classification
Class II
Quantity
312
Official record key
device-enforcement:Z-1061-2014

Official wording

Reason: Potential collision risk when using XVI and external beam shaping devices.

Code information: Model 4.2.1

Distribution pattern: Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential collision risk when using XVI and external beam shaping devices.