# FDA recall Z-2840-2018

> **Elekta, Inc.** · Class II · device recall initiated 2017-12-01.

## Product

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

## Reason for recall

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

## 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, 

## Key facts

- **Recall number:** Z-2840-2018
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-01
- **Report date:** 2018-08-29
- **Termination date:** 2019-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2840-2018

## Citation

> AI Analytics. FDA recall Z-2840-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2840-2018. Source: US FDA. Licensed CC0.

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