FDA Device recall Z-0096-2019
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE M…
- FDA Device
- Class II
- ongoing
- Published 2018-10-17
On 2018-10-17 the FDA classified a Class II recall of GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE M… by Ge Healthcare Finland Oy, citing when multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0096-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-09-04 |
| Published | 2018-10-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare Finland Oy |
| Distribution | US |
Product
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
Reason
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
Identifiers
| code_info | Serial Numbers: No UDI: SKA14365373GA SKA16085338SA SKA16085415SA SED11178711GA SED11178722GA SED11178730GA SED…Serial Numbers: No UDI: SKA14365373GA SKA16085338SA SKA16085415SA SED11178711GA SED11178722GA SED11178730GA SED11178731GA SED12384211GA SKA16065074SA SKA16065096SA SKA16105698SA SKA16105700SA SED11148380GR SED11168558GR SED11229587GR SED12183123GA SED12183126GA SED12273483GA SED12353647GA SED12353648GA SED12363714GA SED12363728GA SED12373928GA SED09320537GA SED11300215GR SED11300224GR SED11300285GR SED11300317GR SED11300318GR SED11420905GR SED11420906GR SED11420913GR SED11420919GR SED11420923GR SED11420926GR SED11420927GR SED11420928GR SED11420929GR SED11420930GR SED11420931GR SED11430946GR SED11430947GR SED11430949GR SED11430967GR SED11430970GR SED11430971GR SED12152834GR SED12152838GR SED12203208GR SED12203211GR SED12203212GR SED12203213GR SED12203254GR SED12203257GR SED12203258GR SED12203259GR SED12253445GR SED12263455GR SKA14365468GA SED11097478GR SED11158484GR SED11229574GR SED11229586GR SED11229600GR SED11290119GR |
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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: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0096-2019%22
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