Recall Z-1854-2022
Barco NV · initiated July 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Codes / lots: a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers
Reason for recall
installation issues
FDA-determined cause: Labeling design
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.
Details
- Recall number
- Z-1854-2022
- Initiated
- July 27, 2022
- Posted by FDA
- September 29, 2022
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Quantity
- 169 devices
- Distribution
- US Nationwide distribution in the states of FL, IL, NJ.
- Recalling firm
- Barco NV, Kortrijk