Reported Jan 22, 2025 · Ongoing
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
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 Infinia II
- Model/Catalog Numbers1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
- Lot codes and dates
590 of 590 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID A5109665, Serial Number 16611 2 H3000WT: UDI/DI N/A, System ID 205408NUC, Serial Number 17419 3 UDI/DI N/A, System ID 256341NRM1, Serial Number 18226 4 UDI/DI N/A, System ID 256494NM1, Serial Number 17133 5 UDI/DI N/A, System ID 256543INF1, Serial Number 17182 6 UDI/DI N/A, System ID 205408INF2, Serial Number 18157 7 UDI/DI N/A, System ID 256429INF1, Serial Number 17557 8 UDI/DI N/A, System ID 256327NUC, Serial Number 17900 9 UDI/DI N/A, System ID 334418INF, Serial Number 17266 10 UDI/DI N/A, System ID 256386HKNM2, Serial Number 16970 11 UDI/DI N/A, System ID 205750INF, Serial Number 16802 12 UDI/DI N/A, System ID 501776INF, Serial Number 17294 13 UDI/DI N/A, System ID 479463INF2, Serial Number 16900 14 UDI/DI N/A, System ID 501202INF, Serial Number 16564 15 UDI/DI N/A, System ID 479967INF, Serial Number 16817 16 UDI/DI N/A, System ID 479549INF, Serial Number 18319 17 UDI/DI N/A, System ID 479751INF, Serial Number 16800 18 UDI/DI N/A, System ID 928214INF, Serial Number 17075 19 UDI/DI N/A, System ID 520868INF, Serial Number 18289 20 UDI/DI N/A, System ID 602588INF, Serial Number 17054 - Amount recalled
- 877 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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