Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of Recalled by GE Healthcare Finland Oy Due to When multiple CARESCAPEMonitor B450 or B850 units are...

Date: September 4, 2018
Company: GE Healthcare Finland Oy
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare Finland Oy directly.

Affected Products

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 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), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

Quantity: 59,000 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Healthcare Finland Oy

GE Healthcare Finland Oy has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report