FDA Device recall Z-0806-2014
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 by Ge Healthcare, citing 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, Respira….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0806-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-05 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: 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, 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 to: electrocardiogram, 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. K992929: The 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 to: emergency 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 to: electrocardiogram, 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.
Reason
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.
Identifiers
| code_info | Serial Number F1DJ2018G H9DJ0236G E1DJ0384G SBG06398779GA A3DJ4203G J2DJ8331G SBG06182479GA SBG06192680GA F2DJ…Serial Number F1DJ2018G H9DJ0236G E1DJ0384G SBG06398779GA A3DJ4203G J2DJ8331G SBG06182479GA SBG06192680GA F2DJ5762G DSH04532005GA G1DJ2217G E2DJ3710G M3EH8966GR L0DJ5294G SBG05463469GA SBG06264541GA M2DJ2447G J3EH5175G L2DJ1220G B0DJ1561G SD007293609GA L2DJ1263G C1DJ8662G A4EH1258G F0DJ3308G SBG06046629GA SD007262789GA AAB04254355GA SD008429849GA B2DJ1915G DSH05293139GA SD008138223GA H9DJ0155GR SD007251995GA H1DJ3351G SBG06046550GA F2DJ5089G DSH05185989GA H2DJ7244G F1DJ1599G M1DJ7820G DSH05318073GA M2DJ3629G L1DJ6712GR D2DJ2937GR K0DJ5004GR SD007335572GA AAB04231070GA H2DJ7075G K1DJ5436G K1DJ4937G F1DJ1095G B0DJ1414G E2DJ3955G E2DJ4138GR F1DJ1219G A2DJ9815G SBG06451891GA A3DJ4322G SBG05514986GA DSH05318052GA C3DJ7072G H2DJ7154G G2DJ6587GR DSH05292993GA DSH04470444GA M2DJ2896G H9DJ0359G E1DJ0785G DSH05293010GA F0DJ3187G SBG06264685GA D0DJ2288G M9DJ1149G A2DJ9164G G0DJ3490G AAB04356778GA F0DJ3109GR SD007462511 |
|---|
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-0806-2014%22
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