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Terminated

CENTURION Vision System

FDA Recall Z-2081-2016 · Posted 2016-06-28

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHQC
Date Initiated2016-05-24
Date Terminated2017-04-13
Product Quantity1 unit

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.

Firm Action

Alcon has already notified the affected customer verbally on May 24, 2016, and via written correspondence on June 1, 2016. The device was corrected on May 26, 2016, and the Power Entry Switch that was removed from the customers CENTURION Vision System did not exhibit a grounding pin susceptible to detachment. For further questions, please call (817) 293-0450.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to Illinois

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121555CENTURION VISION SYSTEMAlcon Laboratories, Inc. · 2012-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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