Elekta Unity 1553106Recalls & reported problems
Elekta Limited · Elekta Unity · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060191071598), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Arcing of Electrodes” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 6, 2023Open, Classified
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Z-1675-2023 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Arcing of Electrodes1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2025Arcing of Electrodes; Insufficient Device Problem Information; Arcing of Electrodes; Insufficient Device Problem Information
THE CUSTOMER REPORTED ARCING IN THE MAGNET BORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22139632 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.