Recall Z-2081-2016— Alcon Research, Ltd.

Name: FDA recall Z-2081-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-24

Class II · Terminated

Class II FDA medical device recall by Alcon Research, Ltd., initiated 2016-05-24, terminated 2017-04-13. It names one FDA 510(k) clearance: K121555. Product: CENTURION Vision System. Reason: The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed..

Recalling firm: Alcon Research, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-05-24
Terminated: 2017-04-13
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K121555 — CENTURION VISION SYSTEMAlcon Laboratories, Inc.·cleared 2012-12-21

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

CENTURION Vision System

Reason for recall

The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.

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