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RecallsAboutBlog

Elekta, Inc.

Elekta, Inc.: 7 recalls listed since January 2026 across FDA.

By year

  • 20267

By agency

  • FDA7

By category

  • Medical Device7

All recalls (7)

Elekta Brachytherapy Applicators

The Fletcher CT/MR Shielded Applicator Set can detach its intrauterine tube tip, which may remain within a patient.

Moderate risk, FDA, , Device defect

MOSAIQ Oncology Information System

MOSAIQ Oncology Information System software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

Moderate risk, FDA, , Software defect

Leksell Vantage Arc System

The Leksell Vantage Arc System has locking mechanisms that may not secure properly, causing coordinate shifting.

Moderate risk, FDA, , Device defect

Leksell Gamma Knife

The Leksell Gamma Knife has an adapter that may not be properly aligned or locked in place.

Moderate risk, FDA, , Device defect

Elekta Leksell GammaPlan Radionuclide RT Treatment Planning System

Leksell GammaPlan treatment planning software has an error that may cause incorrect patient location irradiation.

Moderate risk, FDA, , Device defect

Elekta Synergy, Harmony, Infinity and Versa HD Linear Accelerators

The digital linear accelerators have a manufacturing issue with electrical grounding.

Moderate risk, FDA, , Manufacturing problem

Elekta MOSAIQ Oncology Information System with Particle Therapy License

The Mosaiq Oncology Information System with Particle Therapy License may deliver partial treatment twice, causing overtreatment.

Moderate risk, FDA, , Foreign object
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