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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88166

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

Open FDA event record

Event summary

Timeline bucket
May 17, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mediana Co., Ltd.

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

AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

Z-2096-2021
Recall number
Z-2096-2021
Initiated
May 17, 2021
Classification
Class II
Status
Terminated
Recalling firm
Mediana Co., Ltd.
Quantity
618

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In some cases the equipment fails to power up and/or key or button unresponsive or not working.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In some cases the equipment fails to power up and/or key or button unresponsive or not working.

Code information

Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

Distribution pattern

US Distribution to: Wisconsin only