Recall Z-0724-2018— Elekta Limited

Name: FDA recall Z-0724-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-20

Class II · Terminated

Class II FDA medical device recall by Elekta Limited, initiated 2017-11-20, terminated 2024-03-15. It names one FDA 510(k) clearance: K112613. Product: Integrity R1.2. Reason: Potential for positional errors following automatic table movement (ATM)..

Recalling firm: Elekta Limited
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Terminated: 2024-03-15
Firm location: Crawley, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K112613 — INTEGRITY(TM)Elekta Limited·cleared 2011-12-16

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

Integrity R1.2

Reason for recall

Potential for positional errors following automatic table movement (ATM).

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