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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96078

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

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Event summary

Timeline bucket
June 21, 2021
Product types
Device
Classifications
Class II
Statuses
Completed
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

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

Z-0956-2025
Recall number
Z-0956-2025
Initiated
June 21, 2021
Classification
Class II
Status
Completed
Recalling firm
Murata Vios, Inc.
Quantity
275 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

Code information

Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K

Distribution pattern

Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.