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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85685

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

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Event summary

Timeline bucket
May 15, 2020
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

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor 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-2441-2020
Recall number
Z-2441-2020
Initiated
May 15, 2020
Classification
Class II
Status
Terminated
Recalling firm
Mediana Co., Ltd.
Quantity
180 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failures were found in the temperature measurement function while in the predict mode.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Failures were found in the temperature measurement function while in the predict mode.

Code information

Serial Numbers: 456802000001~456802000180

Distribution pattern

US Nationwide distribution.

Field note

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