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U.S. Department of Health and Human Services

Class 2 Device Recall MNA with the HexaVue IP Integration System

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 Class 2 Device Recall MNA with the HexaVue IP Integration Systemsee related information
Date Initiated by FirmMay 23, 2025
Date PostedFebruary 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1361-2026
Recall Event ID 98266
Product Classification Camera, surgical and accessories - Product Code KQM
ProductBarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Code Information UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactMichelle LaVan
440-2597417
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionAll 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.
Quantity in Commerce10 units
DistributionUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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