FDA Device recall Z-2750-2020
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a…
- FDA Device
- Class II
- terminated
- Published 2020-08-12
On 2020-08-12 the FDA classified a Class II recall of CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a… by Ge Healthcare, citing CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 hos….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2750-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-22 |
| Published | 2020-08-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Reason
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
Identifiers
| code_info | Model: 2087075-001 Serial Numbers: SNA20210164SA, SNA20210031SA, SNA20210045SA, SNA20210064SA, SNA20210319SA, SNA20210…Model: 2087075-001 Serial Numbers: SNA20210164SA, SNA20210031SA, SNA20210045SA, SNA20210064SA, SNA20210319SA, SNA20210330SA, SNA20210348SA, SNA20210361SA, SNA20210362SA, SNA20210375SA, SNA20210376SA, SNA20210377SA, SNA20220003SA, SNA20220005SA, SNA20220007SA, SNA20220018SA, SNA20220022SA, SNA20220026SA, SNA20220045SA, SNA20220047SA, SNA18140024SA, SNA18340072SA, SNA18370025SA, SNA18380001SA, SNA18390009SA, SNA18430002SA, SNA18430059SA, SNA18430088SA, SNA18430116SA, SNA19390023SA, SNA19400056SA, SNA19400143SA, SNA19440048SA, SNA19440069SA, SNA19440071SA, SNA19440122SA, SNA19450008SA, SNA19450025SA, SNA19450128SA, SNA19450136SA, SNA19500072SA, SNA19500073SA, SNA19500080SA, SNA19500084SA, SNA19500086SA, SNA19510001SA, SNA19510005SA, SNA19510007SA, SNA19510012SA, SNA19510027SA, SNA19510053SA, SNA19510055SA, SNA19510103SA, SNA20020119SA, SNA20030070SA, SNA20030071SA, SNA20170022SA, SNA20170080SA, SNA20170082SA, SNA20170112SA, SNA20170113SA, SNA20170116SA, SNA20170117SA, SNA20170118SA, SN |
|---|
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-2750-2020%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.