FDA Device recall Z-0494-2013
GE Healthcare, Dash 3000/4000/5000
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of GE Healthcare, Dash 3000/4000/5000 by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0494-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-26 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
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 to: emergency 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 to: electrocardiogram, 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.
Reason
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.
Identifiers
| code_info | FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA…FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA SD010272518GA SD010272529GA SD010272531GA SD010272533GA SD010272535GA SD010272536GA SD010272537GA SD010272539GA SD010272541GA SD010272542GA SD010272544GA SD010272545GA SD010272546GA SD010272547GA SD010292708GA SD010292709GA SD010292711GA SD010292836GA SD010292904GA SD010292966GA SD010292968GA SD010292969GA SD010292977GA SD010292978GA SD010292980GA SD010292982GA SD010292984GA SD010292985GA SD010292986GA SD010292987GA SD010292988GA SD010292989GA SD010292990GA SD010292991GA SD010292992GA SD010292993GA SD010292994GA SD010292995GA SD010292996GA SD010292997GA SD010292999GA SD010293000GA SD010293106GA SD010293107GA SD010293108GA SD010293109GA SD010293110GA SD010293113GA SD010293114GA SD010293115 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0494-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.