Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

Recall Initiated

July 27, 2022

Posted

September 29, 2022

Recall Number

Z-1854-2022

Quantity

169 devices

Reason for Recall

installation issues

Distribution

US Nationwide distribution in the states of FL, IL, NJ.

Lot / Code Info

a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers

Root 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.