Solar 8000i Patient Monitoring System is used to monitor physiologic… — Class II medical device recall Z-0522-2019
Ongoing recall by GE Healthcare, LLC, reported 2018-12-05, distributed nationwide. The patient monitors may simultaneously restart as designed if all are connected to the same network and a net
| Recall number | Z-0522-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-08-31 |
| Classified | 2018-11-29 |
| Reported by FDA | 2018-12-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BM, BO, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UA, UY, VE, VN, ZA |
Product
Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Reason for recall
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
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-0522-2019. 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.