Elekta, Inc.

4 FDA enforcement actions

4 Total Recalls

0 Class I

4 Class II

0 Class III

Firm Details

Product Types: device
States: GA

All Recalls

Class II: Risk 12/14/2025 device

Due to a manufacturing issue and electrical grounding of systems.
Class II: Risk 12/10/2025 device

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 treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
Class II: Risk 09/30/2025 device

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
Class II: Risk 01/15/2025 device

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.