Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1061-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 25, 2013

Date Posted: February 26, 2014

Recall Number: Z-1061-2014

Event ID: 67230

Reason for Recall:

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

Status: Terminated

Product Quantity: 312

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.

Voluntary or Mandated:

Voluntary: Firm initiated