Cl ll CARESCAPE” Monitor B850

Company: GE Healthcare
Date of Enforcement Report 10/27//2010
Class ll:

PRODUCT
GE Healthcare, CARESCAPE” Monitor B850, Software version 1.0.1.13 and 1.0.2.1 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 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. Recall # Z-1801-2010

REASON
GE Healthcare has become aware of a safety issue associated with the CARESCAPE” Monitor B850 when monitoring ECG. The safety issue includes the potential for a delay in treatment.

RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLLC, Waukesha, WI, letter dated April 22, 2010.

Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
798 units

DISTRIBUTION
CO, MA, NC, WI, and United Kingdom, Switzerland, Sweden, Spain, Singapore, Portugal, Norway Netherlands, Italy, India, Germany, France, Finland, Belgium, and Australia

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15148 Springview St
Tampa, FL 33624
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Partners located in the US (CA, FL, MA, MN) and Italy.