Optima NM/CT 640 — Class II medical device recall Z-0858-2021
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-0858-2021 |
|---|---|
| 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 | 7 units |
| Serial numbers | 64GY51017, 64GY51020, 64GY51021, 64GY51022, 64GZ51028, 64GZ51029, 64GZ51030 |
| Model numbers | 3101RL |
Product
Optima NM/CT 640, Model number 3101RL - 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-0858-2021. 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.