Reported Jan 22, 2025 · Ongoing
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY;…
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 630
- Model/Catalog Numbers1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission
- Lot codes and dates
525 of 525 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0 2 UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1 3 UDI/DI N/A, System ID NT3111, Serial Number 147243HL0 4 UDI/DI N/A, System ID NT3072, Serial Number 151822HL4 5 UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5 6 UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8 7 UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1 8 UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6 9 UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7 10 UDI/DI N/A, System ID NT3076, Serial Number 153537HL6 11 UDI/DI N/A, System ID NT3048, Serial Number 141262HL6 12 UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6 13 UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7 14 UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1 15 UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3 16 UDI/DI N/A, System ID NT3057, Serial Number T2BG1600022/ 146064HL1 17 UDI/DI N/A, System ID NT0005, Serial Number T2AG14040/ 119081HL8 18 UDI/DI N/A, System ID NT3054, Serial Number T2BG1600019/ 144873HL7 19 UDI/DI N/A, System ID NT3070, Serial Number T2BG1600024/ 146363HL7 20 UDI/DI N/A, System ID NT3067, Serial Number T2BG1600031/ 148143HL1 - Amount recalled
- 704 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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