FDA Device recall Z-1775-2018
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Numbe…
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Numbe… by Icu Medical, citing when continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1775-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-05 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Icu Medical |
| Distribution | CA, FL, NC, NE, NY, WA |
Product
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
Reason
When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
Identifiers
| code_info | a. Part Number 58401-000 - UDI (Serial No.): (01)00840619079499(11)170615(21)1647100134 (1647100134), (01)0084061907949…a. Part Number 58401-000 - UDI (Serial No.): (01)00840619079499(11)170615(21)1647100134 (1647100134), (01)00840619079499(11)170912(21)1647100137 (1647100137), (01)00840619079499(11)170912(21)1731100224 (1731100224), (01)00840619079499(11)170914(21)17311002301 (731100230), (01)00840619079499(11)170914(21)1731100228 (1731100228), (01)00840619079499(11)170605(21)1647100140 (1647100140), (01)00840619079499(11)170822(21)1647100135 (1647100135), (01)00840619079499(11)170825(21)1726100215 (1726100215), (01)00840619079499(11)170721(21)1726100214 (1726100214), (01)00840619079499(11)170801(21)1718100164 (1718100164), (01)00840619079499(11)170615(21)1647100139 (1647100139), (01)00840619079499(11)170822(21)1647100146 (1647100146), (01)00840619079499(11)170822(21)1647100136 (1647100136), (01)00840619079499(11)170716(21)1711100147 (1711100147), (01)00840619079499(11)170615(21)1647100143 (1647100143), (01)00840619079499(11)170824(21)1726100204 (1726100204), (01)00840619079499(11)170712(21)1718100166 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2018%22
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