GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector… — Class I medical device recall Z-0370-2019
Terminated recall by GE Healthcare, LLC, reported 2018-11-21, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. A detector can detach and fall.
| Recall number | Z-0370-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-09-14 |
| Classified | 2018-11-13 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2020-10-08 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, CY, DE, ES, FR, GB, GR, GT, HN, IN, IQ, IS, IT, JM, JP, KE, KR, MX, PA, PE, PH, PT, RU, TR, TW, VE, VN, ZA |
| Quantity | 1,166 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 83026002101937 |
Product
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Reason for recall
A detector can detach and fall.
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-0370-2019. 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.