The Recall Desk
HighFDA (Devices)·Z-2081-2016·Announced 2016-07-06

Alcon CENTURION Vision System Recalled for Power Switch Defect

Alcon Research, Ltd. is recalling the CENTURION Vision System because the grounding pin in the power entry switch may detach when the AC power cable is removed.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential electrical safety hazard (grounding pin detachment) where no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Alcon Research, Ltd. is recalling the CENTURION Vision System. The recall involves one unit with serial number 1601444801X that was distributed to Illinois.

The recall was initiated because the grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed. This defect could potentially compromise the safety of the device during use or maintenance.

Consumers and healthcare facilities with the affected unit should contact Alcon Research, Ltd. for instructions on how to proceed. The source text does not specify a particular action such as stopping use immediately, but users should verify if they possess the affected serial number.

The recalled product

Product
CENTURION Vision System
Manufacturer
Alcon Research, Ltd.
Category
Medical Device — Ophthalmic Surgical Equipment
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number 1601444801X

Distribution

Distributed in 1 state:

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