GE Nuclear Medicine Imaging Systems Recalled for Unintended Detector Motion
GE's Varicam, Millennium VG, and Discovery VH nuclear medicine imaging systems may experience unintended detector motion during patient setup or scanning if the gantry software is not the correct version, potentially causing life-threatening injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for life-threatening injury if incorrect gantry software causes unintended detector motion during scanning. No injuries or deaths have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Medical Systems is recalling 21 units of its Varicam, Millennium VG, Millennium VG Hawkeye, and Discovery VH nuclear medicine imaging systems distributed worldwide.
The recalled systems may experience unintended radial detector motion during patient setup or during a patient scan if the system does not have the correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Specific serial numbers affected have been identified in the FDA recall notice. Healthcare facilities operating these systems should review the complete recall information on the FDA website for affected unit serial numbers and further guidance.
The recalled product
- Product
- Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- unintended-motion
- software-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: Millennium VG 1074
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03