Reported Jan 22, 2025 · Ongoing

GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001;…

Ge Medical Systems Israel, Functional Imaging

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING · 4, Hayozma St · Tirat Carmel · N/A

Is this the product you have?

  • GE Healthcare Varicam Millennium VG Discovery VH
  • Model/Catalog Numbers1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
Lot codes and dates

30 of 30 products

Products covered by this recall
#BarcodesProduct as published
1UDI/DI N/A, System ID NM10569, Serial Number 10569
2UDI/DI N/A, System ID NM10570, Serial Number 10570
3UDI/DI N/A, System ID YN0845, Serial Number 10242
4UDI/DI N/A, System ID YN0498, Serial Number 1092
5UDI/DI N/A, System ID YN0440, Serial Number 1003
6UDI/DI N/A, System ID 979764VGH1, Serial Number 77521848
7UDI/DI N/A, System ID NM10225, Serial Number 10225. 2) ASM001092: UDI/DI N/A, System ID 310231VGH1, Serial Number 10539
8UDI/DI N/A, System ID 207795VH, Serial Number 10571
9UDI/DI N/A, System ID 82426070015, Serial Number 10550
10UDI/DI N/A, System ID 82426210010, Serial Number 10595
11UDI/DI N/A, System ID 82426280001, Serial Number 10591
12082426080009UDI/DI N/A, System ID 082426080009, Serial Number 10599
13UDI/DI N/A, System ID H2103NUC06, Serial Number 10582
14UDI/DI N/A, System ID H1404NUC06, Serial Number 10604
15UDI/DI N/A, System ID H2094NUC07, Serial Number 10587
16UDI/DI N/A, System ID YN0984, Serial Number 10543
17UDI/DI N/A, System ID 850260054, Serial Number 10579
18UDI/DI N/A, System ID RU1591NM01, Serial Number 10561
19UDI/DI N/A, System ID RU1457NM01, Serial Number 10553
20UDI/DI N/A, System ID 209526MILVG, Serial Number 10340
Amount recalled
30 units

This recall covers 13 products

The agency filed one notice per product. You are reading one of them; the other 12 are below.

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.