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Recall Observatory FDA recall evidence

Device product

Vios Monitoring System Bedside Monitor Model BSM2050

Z-1292-2025

August 09, 2024

Class II

Product summary

Firm
Murata Vios, Inc.
Event
Event 96252
Status
Ongoing
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-1292-2025

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.