Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is… — Class II medical device recall Z-1266-2019
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-1266-2019 |
|---|---|
| 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 | 35 units |
| Model numbers | 301315NMOPTIMA, 302430NUC640, 303425O640, 303689O640, 316962NM640, 408559O640, 443777NM, 4695537NM11, 515699NM1, 5474055, 630933NM6402, 714456OPT1, 860358O640, 906225NMCT, 970298NM, 970298NM1, H3100JZ, ONMX26503, ONMX26507, ONMX26510, ONMX26511, ONMX26512, ONMX26513, ONMX26514, ONMX26518 and 9 more |
Product
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.
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
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-1266-2019. 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.