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Recall Observatory FDA recall evidence

Device product

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

Z-1854-2022

July 27, 2022

Class II

Product summary

Firm
BARCO NV
Event
Event 90807
Status
Ongoing
Classification
Class II
Quantity
169 devices
Official record key
device-enforcement:Z-1854-2022

Official wording

Reason: installation issues

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    installation issues