Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
FDA device recall Z-1361-2026 · posted 2026-02-12 · Open, Classified
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
- Action taken
- All affected Customers have been contacted by a STERIS Service Technician arranging an onsite inspection of their unit(s) to locate and replace the affected MNA(s). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Diksha Chechi, Quality Manager at 510-439-4500.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KQM
- Quantity affected
- 10 units
- Distribution
- US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
- Date initiated
- 2025-05-23
- Date posted
- 2026-02-12
- Location
- Mentor, OH
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