FDA Device recall Z-0586-2019
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, a…
- FDA Device
- Class II
- ongoing
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, a… by Ge Healthcare, citing patient monitors may restart due to network overload caused by network configuration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0586-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-09-11 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
Reason
Patient monitors may restart due to network overload caused by network configuration.
Identifiers
| code_info | All monitors |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-23 · Ge Healthcare - Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0586-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.