Recall Z-1665-2023— Elekta, Inc.

Name: FDA recall Z-1665-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-05

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2023-05-05. It names one FDA 510(k) clearance: K210500. Product: Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy. Reason: A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601.

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K210500 — Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited·cleared 2021-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

Reason for recall

A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601

Data sourced from openFDA. This site is unofficial and independent of the FDA.