Recall Z-2840-2018— Elekta, Inc.

Name: FDA recall Z-2840-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-01

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2017-12-01, terminated 2019-11-05. It names one FDA 510(k) clearance: K051932. Product: ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD. Reason: There is a potential for an uncontrolled extension of iViewGT / XVI detector arms..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-01
Terminated: 2019-11-05
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K051932 — ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5Elekta, Inc.·cleared 2005-08-12

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 Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD

Reason for recall

There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.

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