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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96133

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 06, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Murata Vios, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1169-2025
Recall number
Z-1169-2025
Initiated
June 06, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Murata Vios, Inc.
Quantity
44 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500

Distribution pattern

US Nationwide distribution in the state of NY.