Elekta, Inc.: ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD

Recall number

Z-2840-2018

Recalling firm

Elekta, Inc.

Product

ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD

Status

Terminated

Initiated

2017-12-01

Posted

not on file

Terminated

2019-11-05

Reason

There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.

Root cause

Component design/selection

Action

On December 6, 2017 Elekta sent notification to their customers informing them the following: Description of Problem: Elekta has identified that if the microswitch within the middle arm is not set up correctly, it is possible for the MV or kV detector arm to extend due to gravity. When the detector arm is fully open there is no risk. Details: In order for an uncontrolled extension to occur on a detector arm, the following conditions must be present: The microswitch (within the Solenoid Limit Switch of the PCB assembly in the middle arm) is activated incorrectly. The detector-locked solenoid is not fully engaged in the interface bracket. This is most likely to lead to a potential collision in the following scenarios: iViewGT - The detector arm is opened or closed above the patient, when the gantry angle is at 180 ( 45). XVI - The detector arm is opened or closed above the patient, when the gantry angle is at 90 ( 45) Clinical Impact: It is possible that a collision with the extended detector arm can cause serious injury. Recommended User Action: Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions For Use (IFU). Elekta Corrective Actions: Elekta Field Service Representatives will do checks to make sure that that the microswitch activates only when the detector-locked solenoid is fully engaged in the interface bracket. If you have any concerns, contact your Elekta Field Service Representatives who are aware of how to do these checks. This notice has been provided to the appropriate Regulatory Authorities. We sincerely apologize for any inconvenience this action may cause and thank you in advance for your cooperation.

Quantity

2,998

Distribution

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Alaska, District of Columbia, Hawaii and Puerto Rico Albania, Algeria Antigua and Barbuda Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Lao People's Democratic Republic, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Viet Nam and Zimbabwe

Lot, serial or model codes

All Digital Accelerators with XVI or iViewGT

510(k) numbers

["K051932"]

PMA numbers

not on file

Product code

IYE

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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