Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

Recall Insight

This FDA Devices action (record #Z-1169-2025) was formally reported on February 19, 2025, with the manufacturer initiating the action on June 6, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Murata Vios, Inc. is listed as the recalling firm, operating out of Woodbury, MN. Federal records indicate 44 systems units are affected.

The documented reason for this recall is: A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be inco… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.