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Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System

FDA Recall #Z-2098-2025 — Class II — June 20, 2025

Recall #Z-2098-2025 Date: June 20, 2025 Classification: Class II Status: Ongoing

Product Description

Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System

Reason for Recall

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.

Recalling Firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Tirat Carmel, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

21

Distribution

Worldwide - US Nationwide distribution.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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