FDAHealthJune 20, 2025

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System

⚠️ Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: June 20, 2025

Worldwide - US Nationwide distribution.

What's affected?

Product: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Brand: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Lot code: Serial Numbers: Millennium VG 1074; "Varicam Millennium VG Discovery VH" 1003 1092 10147 10242 10374 10378 10539 10543 10550 10553 10561 10569 10570 10571 10579 10582 10587 10599 10604 3101-1502

Additional details

Serial Numbers: Millennium VG 1074; "Varicam Millennium VG Discovery VH" 1003 1092 10147 10242 10374 10378 10539 10543 10550 10553 10561 10569 10570 10571 10579 10582 10587 10599 10604 3101-1502

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 21.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.