Z-1927-2020 Class II Terminated
FDA device recall Z-1927-2020 was initiated by ICU Medical, Inc. on February 14, 2020 and is designated Class II. Reason for recall: Firm identified software issues which leads to the patient ID and patient information not being stored in the system. The recall status is terminated (terminated May 3, 2023). Affected quantity: 123 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- February 14, 2020
- Termination Date
- May 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 units
Product Description
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.
Reason for Recall
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Distribution Pattern
US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.
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.