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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84790

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

Open FDA event record

Event summary

Timeline bucket
November 17, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edan Diagnostics

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

EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)

Z-1256-2020
Recall number
Z-1256-2020
Initiated
November 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Edan Diagnostics
Quantity
7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

Code information

Serial Numbers: 260638-M16400850001 260638-M17211500001 260638-M17211500002 260638-M17211500003 260638-M17211500004 261350-M17A03030001 261350-M17A03030002

Distribution pattern

U.S. Nationwide distribution in the state of CA.