NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual… — Class II medical device recall Z-1261-2019
Terminated recall by GE Healthcare, LLC, reported 2019-05-08. During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector scr
| Recall number | Z-1261-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-03-20 |
| Classified | 2019-05-02 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2020-10-05 |
| Countries outside the US | AT, CA, CH, DE, ES, FR, GB, HR, IN, IT, JP, KR, NL, PL, PT, SE, SK, ZA |
| Quantity | 37 units |
| Model numbers | 0850260165, 0850260166, 100039NU05, 225761NM, 225761NM1, 256737NM, 304526D830, 361275NM830, 362759NU01, 410554NM, 479338N830, 5376204-32-1, 573458NM, 585396NM, 585786NM830, 603742NM830, 615316NM830, 631726D830, 705743DNM830, 716862NM830, 718238D830, 752030NU01, 772468NM830, 813315D830, 813874D830 and 51 more |
Product
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for 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. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation console.
Reason for recall
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
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.