Discovery NM 630 — Class II medical device recall Z-0856-2021
Terminated recall by GE Healthcare, LLC, reported 2021-01-20. GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leadin
| Recall number | Z-0856-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2021-01-13 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2026-08-21 |
| Quantity | 81 units |
| Serial numbers | 63GY50107, 63GY50108, 63GY50110, 63GY50112, 63GY50116, 63GY50119, 63GY50120, 63GY50121, 63GZ50138NM, 63GZ50139, 63GZ50141, 63GZ50142, 830, 830NM, 830Y60072, 830Y60073, 830Y60077, 830Y60078, 830Y60079, 830Y60080, 830Y60081, 830Y60082, 830Y60083, 830Y60084, 830Y60085 and 58 more |
| Model numbers | H3101RH, H3910AC, H3910AG |
Product
Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Reason for recall
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
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-0856-2021. 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.