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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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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