Barco MDSC-8527 NXF Medical Display decoder functionality blocked
Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in 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: This is an FDA Class II medical device recall with a functional defect affecting diagnostic capability. Since no illnesses, injuries, or hospitalizations have been reported, and the hazard is functional rather than structural, the severity is High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Barco N.V. is recalling certain MDSC-8527 NXF medical display units (Part Number K9352421) due to a manufacturing defect involving I2C cables. The defect blocks the functionality of the built-in MNA decoder, preventing the device from properly decoding certain medical data or signals.
The recall affects a limited batch of MDSC-8527 NXF units with UDI/DI 05415334043312, distributed in the state of New Jersey. Two units are involved in this recall.
Consumers and healthcare facilities that have received or are operating one of the affected units should contact Barco immediately. The device should not be used for its intended diagnostic purpose until Barco provides a repair or replacement solution.
The recalled product
- Product
- Barco MDSC-8527 NXF, Part Number K9352421
- Manufacturer
- Barco N.V.
- Category
- Medical Device — Medical Display
- Hazard
- decoder-failure
- manufacturing-defect
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 (1)
- UDI/DI 05415334043312
Distribution
Distributed nationwide across the United States.
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