FDAClass IIJuly 16, 2025

Varicam recall: Software Issue

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

Why was Varicam recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Recalling firm
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Quantity
21
Distribution
Worldwide - US Nationwide distribution.
Recall date
July 16, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls