CLASS II ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report

Varicam, Millennium VG, Millennium VG Hawkeye recalled

GE Medical Systems Israel Functional Imaging is recalling Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System, distributed nationwide in the US. The recall was initiated on 20 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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 recalled21

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2098-2025
FDA event ID: 97193
Recalling firm: GE Medical Systems Israel Functional Imaging, Tirat Carmel, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jun 2025
FDA classified: 8 Jul 2025
Reported: 16 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Jun 2025	Recall initiated by company
8 Jul 2025	Classified by FDA	+18 days
16 Jul 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots 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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97193

This product is part of a recall event; the main page for the event is Infinia II Hawkeye 4 Nuclear Medicine system recalled.

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025	CLASS II	Infinia II Hawkeye 4 Nuclear Medicine system recalled	GE Medical Systems Israel Functional Imaging	Device Malfunction	Nationwide

More recalls from GE Medical Systems Israel Functional Imaging

All 41

Reported	Class	Recall	Company	Reason	Where
28 Jan 2026Device	CLASS II	GE Healthcare Omni Legend, sold under the following names recalled	GE Medical Systems Israel Functional Imaging	Other	Nationwide
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21 Jan 2026Device	CLASS II	SMV DSX New Line, System, Tomography, Computed, Emission recalled	GE Medical Systems Israel Functional Imaging	Other
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