GE Healthcare — Class II medical device recall Z-0813-2013
Terminated recall by GE Healthcare, LLC, reported 2013-02-20, distributed nationwide. GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occ
| Recall number | Z-0813-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-06-13 |
| Classified | 2013-02-13 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2016-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MT, MX, MY, NG, NO, NP, NZ, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TT, TW, UA, UY, ZA |
| Quantity | 119,262 |
Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
Reason for recall
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m
Machine access
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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.