Class 2 Device Recall Vios Monitoring System Bedside Monitor

• Date Initiated by Firm: June 06, 2023
• Date Posted: February 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1169-2025
• Recall Event ID: 96133
• 510(K)Number: K172586
• Product Classification: Monitor, cardiac (incl. Cardiotachometer & rate alarm) - Product Code DRT
• Product: Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
• Code Information: All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500
• FEI Number: 3015328411
• Recalling Firm/ Manufacturer: Murata Vios, Inc.; 700 Commerce Dr Ste 190; Woodbury MN 55125-9239
• For Additional Information Contact: Customer Service Team; 866-990-1435
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DRT