ELEKTA SOLUTIONS AB recalls
Every recall we track for ELEKTA SOLUTIONS AB — 2 in all, from 2021–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
2 recalls since 2017.
All FDA recall records for ELEKTA SOLUTIONS AB since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled ELEKTA SOLUTIONS AB product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All ELEKTA SOLUTIONS AB recalls
2 shown- Lower riskMedical device
ELEKTA SOLUTIONS AB recalls MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes:
ELEKTA recalls specific MOSAIQ oncology software versions where appending care plans with medication orders may not match intended schedules. Affected users should check software versions and UDI codes.
ELEKTASep 17, 2025 - Use cautionMedical device
ELEKTA SOLUTIONS AB recalls Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta
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.
ElektaSep 28, 2021
ELEKTA SOLUTIONS AB recall questions
How many recalls has ELEKTA SOLUTIONS AB had?
2 recalls from ELEKTA SOLUTIONS AB are on record with U.S. safety agencies, from 2021–2025.
What is the most recent ELEKTA SOLUTIONS AB recall?
ELEKTA SOLUTIONS AB recalls MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes:, dated Sep 17, 2025. Every ELEKTA SOLUTIONS AB recall is listed on this page, newest first.
What should I do if I have a recalled ELEKTA SOLUTIONS AB product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new ELEKTA SOLUTIONS AB recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.