GE Healthcare — Class II medical device recall Z-2115-2013
Terminated recall by GE Healthcare, LLC, reported 2013-09-04, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Re
| Recall number | Z-2115-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2013-04-03 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2016-07-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HN, HU, ID, IL, IN, IQ, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MX, MY, NG, NL, NO, NP, NZ, PA, PE, PH, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SV, TH, TR, TT, TW, UY, VE, ZA |
| Serial numbers | 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 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2115-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.