Display adapters recalled after the wrong configuration file was used
Steris is recalling 10 units of the Barco MNA with HexaVue IP Integration System because the supplier used the incorrect configuration file for a limited batch of adapter components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an incorrect configuration file used in manufacturing, with no stated consequence or reported harm.
Plain-English summary
The Barco MNA with the HexaVue IP Integration System, model/catalog number MNA-6x0-H, is being recalled by Steris Corporation.
The record states this is a sub-recall of event RES 96885, and that the supplier identified that during their manufacturing process for a limited batch of MNA-6x0 adapter components the incorrect configuration file was used.
The record lists 10 units under UDI-DI 00724995220570, with serial numbers recorded in the enforcement record. Distribution was nationwide in the United States, in Florida, North Carolina, New York, Ohio, Tennessee, Texas and Virginia. The FDA has classified the action as Class II.
The record names no consequence and reports no injuries. Facilities should follow Steris' instructions.
The recalled product
- Product
- Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
- Manufacturer
- Steris Corporation
- Affected units
- 10
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 (11)
- UDI-DI: 00724995220570
- Serial Numbers for MNAs: 2531542441
- 2531542470
- 2531543549
- 2531543611
- 2531572419
- 2531572433
- 2531572440
- 2531588558
- 2531593768
- and 2531595829
Distribution
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