Discovery 670 DR — Class II medical device recall Z-0857-2021
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-0857-2021 |
|---|---|
| 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 | 52 untits |
| Serial numbers | 870DR, 870Y64056, 870Y64057, 870Y64058, 870Y64061, 870Y64063, 870Y64064, 870Y64065, 870Y64066, 870Y64067, 870Y64068, 870Y64069, 870Y64070, 870Y64074, 870Y64077, 870Y64078, 870Y64079, 870Y64080, 870Y64081, 870Y64082, 870Y64083, 870Y64084, 870Y64085, 870Z64113, 870Z64114 and 28 more |
| Model numbers | 3100Q, 3100XB, H3100AS, H3100BT, H3100XF |
Product
Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
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-0857-2021. 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.