FDA recall, , Moderate risk
Steris Barco MNA with HexaVue IP Integration System
The Barco MNA with the HexaVue IP Integration System may have an incorrect configuration file.
Summary by Recall Canary from the FDA notice
What happened
This is a sub-recall of event RES 96885.
US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Barco MNA with the HexaVue IP Integration System
- Model number
- MNA-6x0-H
- UDI-DI
- 00724995220570
- 2531542441
- 2531542470
- 2531543549
- 2531543611
- 2531572419
- 2531572433
- 2531572440
- 2531588558
- 2531593768
- 2531595829
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Florida, North Carolina, New York, Ohio, Tennessee, Texas, and Virginia.
- Company
- Steris CorporationMentor, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98266
- Recall number
- Z-1361-2026
- Quantity recalled
- 10 units
All recalls from Steris Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
