Reported Mar 12, 2014 · Terminated
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On-…
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?
- GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module 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 medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following
- parameters for all patient populationselectrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for
- adult and pediatric patient populationsanesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM
- Lot codes and dates
- Mfg Lot or Serial #SE
2,827 of 2,827 codes
PA2314840PA2314841PA2314842PA2314843PA2314844PA2314845A1RF3176GA1RF3638GRA2RF1052GB1RF4038GRB3G44377GB3G44511GB3G44515GB3RF4960GC1RF4686GC1RF4793GC1RF4802GC1RF4827GRD2RF2744GD2RF2778GRD2RF2795GD2RF2796GD2RF2797GD2RF2798GD2RF2799GD2RF2814GD2RF2815GD2RF2816GD2RF2817GD2RF2818GD2RF2819GD2RF2820GD2RF2821GD2RF2822GD2RF2823GD2RF2824GD2RF2825GD2RF2826GD2RF2827GD2RF2828GD2RF2829GD2RF2830GD2RF2831GD2RF2832GD2RF2833GD2RF2834GD2RF2835GD2RF2836GD2RF2837GD2RF2838GD2RF2839GD2RF2840GD2RF2841GD2RF2842GD2RF2843GD2RF2844GD2RF2845GD2RF2846GD2RF2847GD2RF2848G
- Mfg Lot or Serial #
- Amount recalled
- 10,211 (7,549 units US, 2,662 units 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
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AV
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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