Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Summary
The FDA issued a Class II for Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine Sys by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Reason: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software ins.
Details
Source
Device Recall
External ID
Z-2098-2025
Action Date
2025-07-16
Status
Ongoing
Category
device
Product Description
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Lot/Code Info: 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
Quantity Affected: 21
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.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-20
Company
Tirat Carmel, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING have FDA actions?
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2098-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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