GE Healthcare Millennium VG — Class II medical device recall Z-1279-2015
Terminated recall by GE Healthcare, reported 2015-03-25, distributed nationwide. GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG syste
| Recall number | Z-1279-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-03-05 |
| Classified | 2015-03-13 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-08-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CN, CO, CY, CZ, DE, DK, EE, ES, FR, GB, GR, IL, IN, IT, JP, KR, MX, NL, NO, PE, PL, PT, RU, SE, SK, TH, TR, TW, UA, UY |
| UPC / GTIN / UDI-DI | 08302603135243, 08302621006334 |
Product
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform 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 optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
Reason for recall
GE Healthcare has recently become aware of a potential safety issue due to a collimator falling off a VG system during a Quality Control check, while the detectors were rotating. No injuries have been reported to date
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-1279-2015. 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.