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U.S. Department of Health and Human Services

Class 2 Device Recall The CARESCAPE" Monitor B850 version and

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  Class 2 Device Recall The CARESCAPE" Monitor B850 version and see related information
Date Initiated by Firm May 06, 2010
Date Posted June 11, 2010
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-1801-2010
Recall Event ID 55352
510(K)Number K092927  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare, CARESCAPE" Monitor B850, Software version and

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.
Code Information Parent SN 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Recalling Firm/
Ge Healthcare, Llc
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action The customers were sent on May 6, 2010, a GE Healthcare "Urgent Medical Device Correction" letter dated April 22, 2010. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter listed the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to immediately discontinue use of the "Update Lead Set" function until the device software has been upgraded. If you have any questions regarding this medical device correction or identification of affected items, please contact Technical Support at 1-800-558-7044, or your local service representative.
Quantity in Commerce 798 units. (229 USA, 569 OUS)
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.