FDA Device recall Z-2115-2013
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000
- FDA Device
- Class II
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class II recall of GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2115-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-03 |
| Published | 2013-09-04 |
| 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.
Reason
GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
Identifiers
| code_info | Mfg Lot or Serial # AAB04397901GR SD007210479GR SD007231230GR SD007241751GR SD007366729GR SD007387285GR SD007387…Mfg Lot or Serial # AAB04397901GR SD007210479GR SD007231230GR SD007241751GR SD007366729GR SD007387285GR SD007387288GR SD007387291GR SD007387292GR SD007387294GR SD007439614GR SD008056174GR SD008076950GR SD008087478GR SD008138396GR SD008168769GR SD008219818GR SD008219821GR SD008356627GR SD008388272GR SD008388551GR SD008419461GR SD008419463GR SD008419495GR SD008421124GR SD008429787GR SD008429950GR SD008452355GR SD008452399GR SD008463177GR SD008516155GR SD008516281GR SD009037533GR SD009047690GR SD009088931GR SD009088944GR SD009099025GR SD009119669GR SD009121032GR SD009121171GR SD009129978GR SD009141371GA SD009141699GR SD009151940GA SD009182687GR SD009182701GR SD009182715GR SD009193075GR SD009193076GR SD009193084GR SD009193086GR SD009223767GR SD009223886GR SD009234001GR SD009234021GR SD009244557GR SD009244558GR SD009244559GR SD009244560GR SD009244564GR SD009244732GR SD009244820GR SD009255010GR SD009316784GR SD009316799GR SD00 |
|---|
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-2115-2013%22
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