Reported Dec 26, 2012 · Terminated
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct…
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, Dash 3000/4000/5000. The 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, respiratory intensive care, coronary care, medical intensive care, pediatric 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 limited toelectrocardiogram, invasive blood pressure, noninvasive blood pressure (NBP), heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORKTM 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
- Lot codes and dates
- FMI# &
- Descr36080 DASH 3/4/5k Custom Auto NBP System ID (As required)
2,169 of 2,169 codes
SD010210331GASD010262074GASD010262088GASD010272286GASD010272290GASD010272298GASD010272299GASD010272300GASD010272304GASD010272306GASD010272307GASD010272308GASD010272518GASD010272529GASD010272531GASD010272533GASD010272535GASD010272536GASD010272537GASD010272539GASD010272541GASD010272542GASD010272544GASD010272545GASD010272546GASD010272547GASD010292708GASD010292709GASD010292711GASD010292836GASD010292904GASD010292966GASD010292968GASD010292969GASD010292977GASD010292978GASD010292980GASD010292982GASD010292984GASD010292985GASD010292986GASD010292987GASD010292988GASD010292989GASD010292990GASD010292991GASD010292992GASD010292993GASD010292994GASD010292995GASD010292996GASD010292997GASD010292999GASD010293000GASD010293106GASD010293107GASD010293108GASD010293109GASD010293110GASD010293113GA
- Amount recalled
- 119,260 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors.
This product could cause temporary or reversible health problems — stop using it.
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