Reported Feb 12, 2014 · Terminated
CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility
- Product UsageThe 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 (BE), 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
- Lot codes and dates
- serial numbers
2,173 of 2,173 codes
SEG09270517HXSEG09270549HXSEG09270551HXSEG09270553HXSEG09270554HXSEG09270557HXSEG09270559HXSEG09270561HXSEG09270562HXSEG09270563HXSEG09270564HXSEG09270565HXSEG09270566HXSEG09270567HXSEG09270568HXSEG09270569HXSEG09270583HXSEG09270584HXSEG09270585HXSEG09270587HXSEG09270588HXSEG09270589HXSEG09270591HXSEG09270592HXSEG09280596HXSEG09280597HXSEG09280598HXSEG09280599HXSEG09280600HXSEG09280601HXSEG09280602HXSEG09280603HXSEG09280604HXSEG09280605HXSEG09280606HXSEG09280607HXSEG09280608HXSEG09280609HXSEG09280610HXSEG09280611HXSEG09280612HXSEG09280613HXSEG09280614HXSEG09280615HXSEG09280616HXSEG09280617HXSEG09280618HXSEG09280619HXSEG09280620HXSEG09280621HXSEG09280622HXSEG09280623HXSEG09280624HXSEG09280625HXSEG09310656HXSEG09310657HXSEG09310658HXSEG09310659HXSEG09310660HXSEG09310661HX
- serial numbers
- Amount recalled
- 12, 945 units (6,239 US, 6,706 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
There is a potential for communication loss associated with the F5-01 Frame when connected to CARESCAPE Patient Data Module (PDM) in the CARESCAPE Monitor B850. The PDM patient parameter acquisition module can sometimes spontaneously lose the communication with the host patient monitor when attached to the F5-01 Frame due to an issue with the PDM Ethernet communication hardware. The communicatio
This product could cause temporary or reversible health problems — stop using it.
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