Recall – Hemodynamic monitoring system fails to save patient information

Company: ICU Medical, Inc.
Date of Enforcement Report: 5/13/2020
Class II

PRODUCT

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.

Recall Number: Z-1927-2020

REASON

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

RECALLING FIRM/MANUFACTURER

ICU Medical, Inc. on 2/14/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

123 units

DISTRIBUTION

US Nationwide

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  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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