Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
FDA device recall Z-1854-2022 · posted 2022-09-29 · Open, Classified
Recall details
- Recalling firm
- BARCO NV
- Reason for recall
- installation issues
- Action taken
- 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 and ask them to evaluate if their installations must be adapted. 4. Fill out and send back Response Form 2 to Barco Key Account Manager after completion of the actions.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- DXJ
- Quantity affected
- 169 devices
- Distribution
- US Nationwide distribution in the states of FL, IL, NJ.
- Date initiated
- 2022-07-27
- Date posted
- 2022-09-29
- Location
- Kortrijk, Bulgaria
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |