Use cautionMedical device recall · FDA · Published September 28, 2021
Elekta Medical Linear Accelerator Recall: Risk of Diode Failure
Elekta recalls Harmony Pro and Infinity models due to risk of diode failure causing potential injury. Affected units have specific serial numbers and UDI codes.
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 SOLUTIONS ABBox 7593, KUNGSTENSGATAN 18 · Stockholm, Sweden
“Elekta Medical Linear Accelerator Recall: Risk of Diode Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61745-elekta-medical-linear-accelerator-recall-risk-of-diode-failure. Based on FDA recall #Z-0115-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0115-2022%22&limit=1).
The FDA announced on Sept. 28, 2021, that ELEKTA SOLUTIONS AB voluntarily recalled specific Elekta Medical Linear Accelerators due to a potential diode failure hazard. The agency issued recall number Z-0115-2022 for the affected devices.
How to tell if you have it
Elekta Harmony Pro, REF 1555143
Elekta Infinity, REF 1552091
Elekta Versa HD, REF 1552093
UPC 05060191071543
UPC 05060191071574
UPC 05060191071604
The hazard
According to the FDA, there is a risk that 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 SOLUTIONS AB had one other recall on record since Sept. 17, 2025. Other recent recalls of similar products include Elekta Medical Linear Accelerators: Electrical Grounding Hazard (Dec. 14, 2025) and Elekta Geneva Brachytherapy Applicator Recall (April 3, 2026).
How to tell if you have this one
Check for Elekta Harmony Pro (serial #441009) or Infinity (serial #156645) with specific UDI codes listed in the recall notice. The Versa HD model (serials 156646, 156477, 156648) is also affected.
Brand
Elekta
Product
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Identify your unit's serial number and UDI code to confirm if it's affected by this recall.
Where it went and when
Where it was distributed
Distributed in North Carolina and North Dakota.
Listed by the agency
Not listed
FDA distribution: “Distribution was to ND and NC. There was no military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: North Carolina, North Dakota.
Recall timeline
FDA terminated this recall 2.7 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-0115-2022 (September 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0115-2022 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.