Reported Jan 22, 2025 · Ongoing
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; 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 Discovery NM/CT 670 CZT
- Model/Catalog Numbers1) H3906AB; System, Tomography, Computed, Emission
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 840682121446UDI/DI 840682121446, System ID UX2305NU03, Serial Number CZTV29005 2 840682121446UDI/DI 840682121446, System ID M4166103, Serial Number CZTV29006 3 840682121446UDI/DI 840682121446, System ID 00243NUC22, Serial Number CZTW29008 4 840682121446UDI/DI 840682121446, System ID 00222NUC07, Serial Number CZTW29009 5 UDI/DI N/A, System ID 604875D670B, Serial Number CZTW29007 6 UDI/DI N/A, System ID NT6200, Serial Number AD7W38007 7 UDI/DI N/A, System ID NT6201, Serial Number AD7X38017 8 UDI/DI N/A, System ID NT6100, Serial Number AP7W37001. - Amount recalled
- 8 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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