GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001
Summary
The FDA issued a Class II for GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) A by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Reason: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear .
Details
Source
Device Recall
External ID
Z-0900-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
Lot/Code Info: 1) ASM000085: UDI/DI N/A, System ID NM10569, Serial Number 10569; UDI/DI N/A, System ID NM10570, Serial Number 10570; UDI/DI N/A, System ID YN0845, Serial Number 10242; UDI/DI N/A, System ID YN0498, Serial Number 1092; UDI/DI N/A, System ID YN0440, Serial Number 1003; UDI/DI N/A, System ID 979764VGH1, Serial Number 77521848; UDI/DI N/A, System ID NM10225, Serial Number 10225. 2) ASM001092: UDI/DI N/A, System ID 310231VGH1, Serial Number 10539; UDI/DI N/A, System ID 207795VH, Serial Number 10571; UDI/DI N/A, System ID 82426070015, Serial Number 10550; UDI/DI N/A, System ID 82426210010, Serial Number 10595; UDI/DI N/A, System ID 82426280001, Serial Number 10591; UDI/DI N/A, System ID 082426080009, Serial Number 10599; UDI/DI N/A, System ID H2103NUC06, Serial Number 10582; UDI/DI N/A, System ID H1404NUC06, Serial Number 10604; UDI/DI N/A, System ID H2094NUC07, Serial Number 10587; UDI/DI N/A, System ID YN0984, Serial Number 10543; UDI/DI N/A, System ID 850260054, Serial Number 10579; UDI/DI N/A, System ID RU1591NM01, Serial Number 10561; UDI/DI N/A, System ID RU1457NM01, Serial Number 10553; UDI/DI N/A, System ID 209526MILVG, Serial Number 10340; UDI/DI N/A, System ID 416469DVH, Serial Number 10384; UDI/DI N/A, System ID CY1088MN04, Serial Number 10360; UDI/DI N/A, System ID Not Available, Serial Number 81251648; UDI/DI N/A, System ID B5315325, Serial Number 10185. 3) ASM001099: UDI/DI N/A, System ID PER10925, Serial Number 10346. 4) SYS000001: UDI/DI N/A, System ID NM10374, Serial Number 10374; UDI/DI N/A, System ID NM10147, Serial Number 10147; UDI/DI N/A, System ID 334794MILVG, Serial Number 1063; UDI/DI N/A, System ID NM10291, Serial number 10291; UDI/DI N/A, System ID 56948, Serial number 1021. 5) SYS000002: UDI/DI N/A, System ID 949760VG1, Serial Number 10445; UDI/DI N/A, System ID NM10174, Serial Number 10174; UDI/DI N/A, System ID 223410MILVG, Serial Number 1069. 6) SYS000003: UDI/DI N/A, System ID 914734VG, Serial number 10435.
Quantity Affected: 30 units
Reason for Recall
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-18
Company
Tirat Carmel
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 249 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-0900-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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