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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85329

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

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Event summary

Timeline bucket
February 14, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ICU Medical, 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

The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.

Z-1927-2020
Recall number
Z-1927-2020
Initiated
February 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
ICU Medical, Inc.
Quantity
123 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

Code information

All serial numbers of Cogent HMS, List Number(s): 58400-000; 58400-000R; 58403-000; 58401-000 with Software Versions 1.3.3.42 and prior are impacted.

Distribution pattern

US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.