# FDA recall Z-0096-2019

> **GE Healthcare Finland Oy** · Class II · device recall initiated 2018-09-04.

## 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 tran

## Reason for recall

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.

## Distribution

Worldwide Distribution-US Nationwide

## Key facts

- **Recall number:** Z-0096-2019
- **Recalling firm:** GE Healthcare Finland Oy
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-09-04
- **Report date:** 2018-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Helsinki, Finland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2019

## Citation

> AI Analytics. FDA recall Z-0096-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0096-2019. Source: US FDA. Licensed CC0.

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