CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report

Digital Accelerator under the following names recalled by Elekta

Elekta is recalling Elekta Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, distributed nationwide in the US. The recall was initiated on 1 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Digital Accelerators with XVI or iViewGT

Quantity recalled2,998

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2840-2018
FDA event ID: 80690
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 1 Dec 2017
FDA classified: 17 Aug 2018
Reported: 29 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Dec 2017	Recall initiated by company
17 Aug 2018	Classified by FDA	+259 days
29 Aug 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Digital Accelerator under the following names: Elekta Synergy, Synergy S, Synergy recalled?

Yes. Elekta recalled Digital Accelerator under the following names: Elekta Synergy, Synergy S, Synergy on 1 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-2840-2018.

Why was it recalled?

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

Which lots are affected?

All Digital Accelerators with XVI or iViewGT

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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