Recall Z-1826-2020— Elekta Inc

Name: FDA recall Z-1826-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-30

Class II · Terminated

Class II FDA medical device recall by Elekta Inc, initiated 2020-03-30, terminated 2024-04-10. It names 2 FDA 510(k) clearances: K190887, K171123. Product: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument. Reason: A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System..

Recalling firm: Elekta Inc
Classification: Class II
Status: Terminated
Initiated: 2020-03-30
Terminated: 2024-04-10
Firm location: Saint Charles, MO, United States

510(k) clearances named in this recall

2 on FDA's record

K190887 — Leksell Vantage Stereotactic SystemElekta Instrument AB·cleared 2019-08-01
K171123 — Leksell Vantage Stereotactic SystemElekta Instrument AB·cleared 2017-09-15

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

Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument

Reason for recall

A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.

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