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Open, Classified

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

FDA Recall Z-1854-2022 · Posted 2022-09-29

Recalling FirmBARCO NV
Recall StatusOpen, Classified
Product CodeDXJ
Date Initiated2022-07-27
Product Quantity169 devices

Reason for Recall

installation issues

Firm 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 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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173381Nexxis ORBarco N.V. · 2018-02-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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