Elekta Limited
Elekta Limited holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2021, with 6 FDA device recalls on record.
Top product codes for Elekta Limited
FDA recalls by Elekta Limited
- Z-2297-2020 — Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
- Z-1297-2019 — Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
- Z-1109-2019 — Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
- Z-0706-2019 — Elekta Unity
- Z-0724-2018 — Integrity R1.2
- Z-0723-2018 — Agility with Integrity R3.2
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Elekta Limited
Data sourced from openFDA. This site is unofficial and independent of the FDA.