The FDA has posted 12 enforcement recalls from Elekta, Inc. since 2025, none of them Class I (most serious). Most recent report: Jul 15, 2026.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Due to adapter not being properly aligned or locked in place.
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Due to a manufacturing issue and electrical grounding of systems.
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial trea…
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Firm name as filed with the FDA: “Elekta, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.