FDA Device recall Z-0585-2019
B20i Patient Monitor and B20i V2 Patient Monitor
- FDA Device
- Class II
- ongoing
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of B20i Patient Monitor and B20i V2 Patient Monitor 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-0585-2019 |
| 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
B20i Patient Monitor and B20i V2 Patient Monitor. 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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0585-2019%22
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