Reported Jan 29, 2014 · Terminated
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor…
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 HealthcareDash 3000Dash 4000 and Dash 5000
- Product UsageThe intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients
- K073462The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical
- facilities including but not limited toemergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic
- data includes but is not restricted toelectrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs
- K992929The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport
- modes including but not limited toemergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e. ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response. Physiologic
- data includes but is not restricted toelectrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed
- Lot codes and dates
- Serial NumberAAB04305543G*
999 of 999 codes
F1DJ2018GH9DJ0236GE1DJ0384GSBG06398779GAA3DJ4203GJ2DJ8331GSBG06182479GASBG06192680GAF2DJ5762GDSH04532005GAG1DJ2217GE2DJ3710GM3EH8966GRL0DJ5294GSBG05463469GASBG06264541GAM2DJ2447GJ3EH5175GL2DJ1220GB0DJ1561GSD007293609GAL2DJ1263GC1DJ8662GA4EH1258GF0DJ3308GSBG06046629GASD007262789GAAAB04254355GASD008429849GAB2DJ1915GDSH05293139GASD008138223GAH9DJ0155GRSD007251995GAH1DJ3351GSBG06046550GAF2DJ5089GDSH05185989GAH2DJ7244GF1DJ1599GM1DJ7820GDSH05318073GAM2DJ3629GL1DJ6712GRD2DJ2937GRK0DJ5004GRSD007335572GAAAB04231070GAH2DJ7075GK1DJ5436GK1DJ4937GF1DJ1095GB0DJ1414GE2DJ3955GE2DJ4138GRF1DJ1219GA2DJ9815GSBG06451891GAA3DJ4322GSBG05514986GA
1,231 of 1,231 codes
AAB04305543GAAAB04305545GAAAB04305546GAM3EH9802GAAB04305548GAAAB04305549GAAAB04305551GAAAB04305552GAAAB04305553GAAAB04305561GAAAB04305566GAM3EH9889GAAB04305570GAAAB04305572GAAAB04305573GAAAB04305575GAAAB04305586GAAAB04305587GAM3EH9890GAAB04305594GAAAB04305597GAAAB04305598GAAAB04305599GAM3EH9892GAAB04305623GAAAB04305624GAAAB04305625GAAAB04305626GAM3EH9893GM3EH9894GAAB04305644GAAAB04305645GAAAB04305646GAAAB04305647GAAAB04305651GAAAB04305674GAM3EH9895GAAB04305678GAAAB04305679GAAAB04305681GAAAB04305682GAAAB04305684GAAAB04305692GAAAB04305695GAAAB04305699GAAAB04305701GAM3EH9896GAAB04305707GAM3EH9976GAAB04305709GAM3EH9977GM3EH9978GAAB04305737GAAAB04305750GAAAB04305751GAAAB04305756GAAAB04305757GAAAB04305758GAAAB04305759GAM3EH9979G
- Serial Number
- Amount recalled
- 47,125 (38,710 US, 8,415 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
This product could cause temporary or reversible health problems — stop using it.
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