Z-1169-2025Class II

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

Name: Z-1169-2025 Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Creator: Murata Vios, Inc.
Published: 2023-06-06
License: https://open.fda.gov/license/

Murata Vios, Inc. / initiated 2023-06-06 / Open, Classified / root cause: software

FDA source

Murata Vios, Inc. began a recall of Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00 on 2023-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1169-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-06
Posted: 2025-02-12
Recalling firm: Murata Vios, Inc.
Product: Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Product code: DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Reason for recall: 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 incorrectly displayed by the system.
Root cause tag: software
FDA root cause: Software design
Action: A notification letter dated 6/6/23 was sent to customers. The purpose of this letter is to advise you of a premature failure condition that has been identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. The root cause of the underlying issue has been determined to be due to the flex circuitry degrading more rapidly than previously characterized. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system. All SpO2 pulse oximeter sensor model # L2050R have the potential for this identified early failure after approximately 3-4 months of persistent usage. Failure analysis has determined that the flexible circuitry that connects the emitter diode to the light sensor can degrade, causing an open circuit condition to exist. When the SpO2 failure condition is identified, the open circuit condition can be incorrectly reported as a sensor off condition via a technical alarm, and the SpO2 measurement will no longer be provided. This error condition has not resulted in any injury or harm to monitored patients. SpO2 sensor off condition does not affect the ability for the chest sensor to correctly monitor other vital signs. If the noted condition is observed, the SpO2 sensor can be safely unplugged from the distal end of the sensor, near the chest sensor. The sensor should be removed from inventory, properly identified, and returned for analysis. To initiate an RMA, please call customer service at +1-866-990-1434. Murata Vios has identified the root cause of the failure and is in the process of taking the following actions: - Evaluation of alternative reinforced flexible circuit designs that can withstand longer use cycles. - Evaluation of adding semi-rigid material around flexible circuit to minimize stresses due to bending. - Identification of software changes that can correctly identify and discern circuit failure vs. sensor off and provide the appropriate warning mes
Quantity in commerce: 44 systems
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1169-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1169-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-12

Product code DRT

K172586Class IIVios Monitoring System™ Model 2050Vios Medical, Inc. / cleared 2018-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)