Reported Jan 22, 2025 · Ongoing
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5)…
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
- Model/Catalog Numbers
1) 5376204-70-54-22) H2401BC3) H2401CE4) H2401CG5) H3100AG6) H3100JW7) H3100NCSystemTomographyComputedEmission
- Lot codes and dates
563 of 563 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID NT1030, Serial Number T27G16017/ 133897HL9 2 UDI/DI N/A, System ID NT4004, Serial Number T27G15008/ 128542HL8 3 UDI/DI N/A, System ID NT4008, Serial Number T27G16019/ 134674HL1 4 UDI/DI N/A, System ID NT4007, Serial Number T27G16018/ 134286HL4 5 UDI/DI N/A, System ID NT4009, Serial Number T27G16016/ 133646HL0 6 UDI/DI N/A, System ID NT1021, Serial Number T27G1700031/ 147750HL4 7 UDI/DI N/A, System ID NT4010, Serial Number T27G16020/ 134675HL8 8 UDI/DI N/A, System ID NT4012, Serial Number T27G1700032/ 148489HL8 9 UDI/DI N/A, System ID NT4001, Serial Number T27G15002/ 122818HL8 10 UDI/DI N/A, System ID NT4006, Serial Number T27G15013/ 131436HL8 11 UDI/DI N/A, System ID NT4002, Serial Number T27G15003/ 124423HL5 12 UDI/DI N/A, System ID NT4013, Serial Number T27G1700035/ 151334HL0. 2) H2401BC: UDI/DI N/A, System ID 83163862277, Serial Number T2EG1700003/153301HL7 13 UDI/DI N/A, System ID 83103685384, Serial Number T2AG13029/141BH2 14 UDI/DI N/A, System ID 83095572309, Serial Number T2AG13023/132BH1 15 UDI/DI N/A, System ID 83095060278, Serial Number T2AG13025/100091HL8 16 UDI/DI N/A, System ID 83154010867, Serial Number T2EG1600002/0 17 UDI/DI N/A, System ID 83091096402, Serial Number T2DG13001/133BH9 18 UDI/DI N/A, System ID 0910265076, Serial Number T2AG12006/86884HL4 19 UDI/DI N/A, System ID 0910263259, Serial Number T2AG12010/103BH2 20 UDI/DI N/A, System ID 0910263259, Serial Number T2AG12014/103BH2 - Amount recalled
- 859 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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