CENTURION Vision System
FDA device recall Z-2081-2016 · posted 2016-06-28 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HQC
- Quantity affected
- 1 unit
- Distribution
- US Distribution to Illinois
- Date initiated
- 2016-05-24
- Date posted
- 2016-06-28
- Date terminated
- 2017-04-13
- Location
- Fort Worth, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTURION VISION SYSTEM (K121555) | Alcon Laboratories, Inc. | 2012-12-21 |