Reported Jan 22, 2025 · Ongoing
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; 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 ES
- Model/Catalog Numbers1) H3100XF ; System, Tomography, Computed, Emission
- Lot codes and dates
17 of 17 products
Products covered by this recall # Product as published 1 UDI/DI N/A, System ID NT1011, Serial Number T2AG12009/ 88227HL4 2 UDI/DI N/A, System ID NT2002, Serial Number T2AG12011/ 89154HL9 3 UDI/DI N/A, System ID NT1009, Serial Number T2AG12013/ 90088HL6 4 UDI/DI N/A, System ID NT1003, Serial Number T2BG11001/ 79573HL2 5 UDI/DI N/A, System ID NT1004, Serial Number T2AG12003/ 79574HL0 6 UDI/DI N/A, System ID NT1005, Serial Number 84775HL6 7 UDI/DI N/A, System ID NT1020, Serial Number T2AG12012/ 89666HL2 8 UDI/DI N/A, System ID NT1016, Serial Number T2AG13020/ 96237HL3 9 UDI/DI N/A, System ID NT0002, Serial Number 106491HL4 10 UDI/DI N/A, System ID NT2004, Serial Number 105724HL9 11 UDI/DI N/A, System ID NT1012, Serial Number T2AG13016/ 93885HL2 12 UDI/DI N/A, System ID NT1012, Serial Number T2AG13017/ 93885HL2 13 UDI/DI N/A, System ID NT1013, Serial Number 94165HL8 14 UDI/DI N/A, System ID NT1010, Serial Number T2AG12008/ 87697HL9 15 UDI/DI N/A, System ID NT3001, Serial Number 85748HL2 16 UDI/DI N/A, System ID NT1017, Serial Number T2AG13027/ 104213HL4 17 UDI/DI N/A, System ID NT1015, Serial Number T2AG13018/ 94292HL0. - Amount recalled
- 17 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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