Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1927-2020 — 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 param

U.S. FDA — Device Enforcement · United States · 2020-02-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1927-2020
Date of alert
2020-02-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840619099459
Reported risk: Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.