The Recall Desk
HighFDA (Devices)·Z-1854-2022·Announced 2022-10-05

Barco Medical Network Adapter Recalled for Installation Issues

Barco NV recalls 169 NexxisOR system network adapters (models K9303078A and K9303097A) due to installation issues. The affected devices were distributed in Florida, Illinois, and New Jersey.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device used in operating room settings, classified as a risk-of-harm product. No reported injuries or adverse events to date, but the potential for harm in a surgical context and the FDA's Class II designation warrant a High severity rating.

Plain-English summary

Barco NV is recalling 169 Barco Medical Network Adapter (MNA-240) devices that are part of the NexxisOR system. The affected models are K9303078A (all serial numbers, UDI 05415334000056) and K9303097A (all serial numbers, UDI 05415334001657).

The recall was initiated due to installation issues identified with these network adapters. Specific details regarding the nature of the installation issues have not been disclosed in available recall documentation.

These devices were distributed nationwide in Florida, Illinois, and New Jersey. Healthcare facilities and medical professionals who have received these adapters should contact Barco NV for instructions on remediation, repair, or device replacement.

This is a voluntary recall initiated by the manufacturer on July 27, 2022. The FDA classified this as a Class II recall.

The recalled product

Product
Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A
Manufacturer
BARCO NV
Category
Medical Device — Surgical Network Equipment
Hazard
Affected units
169

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • a) K9303078A
  • UDI 05415334000056
  • all serial numbers
  • b) K9303097A
  • UDI 05415334001657

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

Same hazard · installation defect

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