Use cautionMedical device recall · FDA · Published September 17, 2021
Elekta Medical Linear Accelerator Recall: Diode Failure Risk
Elekta recalls specific medical linear accelerators due to risk of diode failure when removed, potentially causing injury. Affected models include Precise Digital, Harmony, Synergy, Infinity, and Versa HD systems.
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Take action
Contact the company
📍Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50 · Atlanta, GA 30346-1227
“Elekta Medical Linear Accelerator Recall: Diode Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61797-elekta-medical-linear-accelerator-recall-diode-failure-risk. Based on FDA recall #Z-0116-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2022%22&limit=1).
The FDA announced on 2021-09-17 that Elekta, Inc. is recalling its Elekta Medical Linear Accelerator (EMLA) devices due to a risk of diode failure in the modulator. The agency classified the recall as Class II.
How to tell if you have it
Elekta Precise Digital Accelerator
Elekta Harmony
Elekta Synergy
Elekta Infinity
Versa HD
The hazard
According to the FDA, there is a risk that the Diode D1 in the Modulator can fail destructively when removed from the machine. The protective tube surrounding the diode may also fail to contain ejected matter.
Context
GovInfoNow's records show Elekta, Inc. has issued 39 other recalls since 2017-06-19. Recent brand recalls include a 2026-05-21 MOSAIQ Oncology System Software Recall for treatment plan loading risk and a 2026-04-03 Advanced Gynecological Applicator Recall for IU tube detachment. Other recent recalls of similar products include a 2026-08-07 Philips Brilliance CT 64 Medical Scanner Recall for unintended radiation risk and 2025-12-15 Philips Allura Xper FD10C and FD10F Medical System Recalls for electrical short-circuits.
How to tell if you have this one
Check if your machine is listed as Precise Digital, Harmony, Synergy, Infinity, or Versa HD. Look for specific model numbers and serial numbers provided in the recall notice.
Brand
Elekta
Product
Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Details
Identify your machine's model number and serial number to confirm if it is affected by this recall.
Contact Elekta
Reach out to Elekta directly for guidance on next steps and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 47 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA, OR, KY, VA, TX, SD, AZ, NJ, MI, WI, ND, MO, WA, OK, PR, NM, NC, ID, CT, DE, LA, MT, TN, CO, UT, MN, IN, RI, IA, DC, ND, AZ, HI, KS, NE, NH, AR, WY, WV, MS, VT…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0116-2022 (September 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0116-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.