Z-2098-2025Class II

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

Name: Z-2098-2025 Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Creator: Ge Medical Systems Israel, Functional Imaging
Published: 2025-06-20
License: https://open.fda.gov/license/

GE Medical Systems Israel, Functional Imaging / initiated 2025-06-20 / Open, Classified / root cause: software

FDA source

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING began a recall of Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System on 2025-06-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2098-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-20
Posted: 2025-07-08
Recalling firm: GE Medical Systems Israel, Functional Imaging
Product: Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Product code: KPS System, Tomography, Computed, Emission
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.
Root cause tag: software
FDA root cause: Software design
Action: Firm notified customers via Urgent Medical Device Correction letter dated June 20, 2025. Customers were instructed to check gantry software version. Instructions to do so are included in the letter. If system has the correct gantry software version, customers may continue to use their system--V.25BK for Infinia Running on Windows2000 (Win2K); C.15BK or C.1523 for Infinia on Windows XP; V.60BK on VG (all operating systems). If the software version is not the correct version, customers should discontinue use of system and contact GE HealthCare Service or local Service Representative. GE HealthCare will correct systems at no cost to the customer. Correction will include a hardware update and, if necessary, a software update. GE HealthCare representatives will contact customers to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 21
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2098-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2097-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-08
Z-2098-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-08

Product code KPS

K953801Class IIVaricamElscint, Inc. / cleared 1995-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)