Z-1292-2025Class II

Vios Monitoring System Bedside Monitor Model BSM2050

Name: Z-1292-2025 Vios Monitoring System Bedside Monitor Model BSM2050
Creator: Murata Vios, Inc.
Published: 2024-08-09
License: https://open.fda.gov/license/

Murata Vios, Inc. / initiated 2024-08-09 / Open, Classified / root cause: labeling and UDI

FDA source

Murata Vios, Inc. began a recall of Vios Monitoring System Bedside Monitor Model BSM2050 on 2024-08-09. FDA classified it as Class II and gives the reason as "Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1292-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-09
Posted: 2025-03-06
Recalling firm: Murata Vios, Inc.
Product: Vios Monitoring System Bedside Monitor Model BSM2050
Product code: DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Reason for recall: Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm sent a single page of instructions to customers on August 9, 2024 via email. Customers were informed that tablets should remain plugged into a wall outlet when the tablet is not in use. The tablet battery should not be allowed to fully deplete at any time during patient monitoring or when not in use.
Quantity in commerce: 50
Distribution: US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
Product codes and lots: 1.56.01 UDI: +B595BSM20500/$$7V1.56.01/16D20230630S 1.57.20 UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y Software Versions 1.56.01 and 1.57.20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1292-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1292-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-06

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)