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Open, Classified

Vios Monitoring System Bedside Monitor Model BSM2050

FDA Recall Z-1292-2025 · Posted 2025-03-06

Recalling FirmMurata Vios, Inc.
Recall StatusOpen, Classified
Product CodeDRT
Date Initiated2024-08-09
Product Quantity50

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.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 2018-06-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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