FDA Medical Device Recalls (openFDA)
Steris Corporation: Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
- Recall number
- Z-1361-2026
- Recalling firm
- Steris Corporation
- Product
- Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
- Status
- Open, Classified
- Initiated
- 2025-05-23
- Posted
- 2026-02-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 10 units
- Distribution
- US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
- Lot, serial or model codes
- UDI-DI: 00724995220570; Serial Numbers for MNAs: 2531542441, 2531542470, 2531543549, 2531543611, 2531572419, 2531572433, 2531572440, 2531588558, 2531593768, and 2531595829
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQM
- Firm FEI
- 1527821
- Firm city
- Mentor
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28