Recall Z-0115-2022— ELEKTA SOLUTIONS AB

Name: FDA recall Z-0115-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-28

Class II · Terminated

Class II FDA medical device recall by ELEKTA SOLUTIONS AB, initiated 2021-09-28, terminated 2024-06-14. It names one FDA 510(k) clearance: K210500. Product: Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.. Reason: There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter..

Recalling firm: ELEKTA SOLUTIONS AB
Classification: Class II
Status: Terminated
Initiated: 2021-09-28
Terminated: 2024-06-14
Firm location: Stockholm, N/A, Sweden

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 (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.

Reason for recall

There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.

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