FDA Device recall Z-1193-2019
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through t…
- FDA Device
- Class I
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class I recall of EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through t… by Edwards Lifesciences, citing potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1193-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-03-21 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
Product
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
Reason
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1193-2019%22
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