Recall Z-1854-2022 ยท DXJ Display, Cathode-Ray Tube, Medical
BARCO NV
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
| Date | Sep 29, 2022 (initiated Jul 27, 2022) |
| Status | Open, Classified |
| Reason | installation issues |
| Root cause | Labeling design |
| Action | Barco NV began notifying its consignees on about August 29, 2022, via email, about the device malfunction and stated that they would be providing an updated instructions for use (IFU). The firm followed with a Field Safety Action, via email on the same day, which described the issue, potential risks and a copy of the updated IFU. The letter requested the following: 1. Fill out and send back Response Form 1 to Barco Key Account Manager after receipt of this Notice. 2. Read the updated installation instructions, including the potential risk of wrong installation. 3. Inform relevant partners an |
| Quantity | 169 devices |
| Distribution | US Nationwide distribution in the states of FL, IL, NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173381 | Nexxis OR Barco N.V., Feb 22, 2018 |