PlainRecalls
FDA Devices Moderate Class II Terminated

CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory qu

Reported: July 3, 2013 Initiated: July 20, 2012 #Z-1567-2013

Product Description

CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.

Reason for Recall

GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
12,779
Distribution
Worldwide Distribution - USA Nationwide including the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, IA, ME, MD,MA, MI, MN, MS, MO, MT, NE,NV,NH, NJ, NM, NY, NC, OR, OK OH, PA, PR, SC, TN, TX, UT, VA, WA, WY, WI, WY, and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK,, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLAND, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.. Recalled by GE Healthcare, LLC. Units affected: 12,779.
Why was this product recalled?
GE Healthcare become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 3, 2013. Severity: Moderate. Recall number: Z-1567-2013.