Reported Jan 22, 2025 · Ongoing
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 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 DR
- Model/Catalog Numbers1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
- Lot codes and dates
72 of 72 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System IDNT7007, Serial Number NT2JG1800001 2 UDI/DI N/A, System IDNT4014, Serial Number T2HG1700003/ 158624HL7 3 UDI/DI N/A, System IDNT4017, Serial Number 157120HL7 4 UDI/DI N/A, System IDNT7001, Serial Number 156620HL7 5 840682140898UDI/DI N/A, System IDNT7005, Serial Number 159731HL9. 2) H2401AW: UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800004 6 840682140898UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800005 7 840682140898UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800006 8 840682140898UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800007 9 840682140898UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800008 10 840682140898UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800009 11 840682140898UDI/DI 840682140898, System ID LY1198CT02, Serial Number NT2JG1800010 12 UDI/DI N/A, System ID N/A, Serial Number T2HG1700001 13 UDI/DI N/A, System ID N/A, Serial Number T2HG1700002 14 UDI/DI N/A, System ID N/A, Serial Number T2HG1800004 15 UDI/DI N/A, System ID N/A, Serial Number T2HG1800001 16 UDI/DI N/A, System ID N/A, Serial Number T2HG1800002 17 UDI/DI N/A, System ID N/A, Serial Number T2HG1800003 18 840682124393UDI/DI N/A, System ID N/A, Serial Number T2JG1800001. 3) H3100AN: UDI/DI 840682124393, System ID 501257D670, Serial Number DDRX34049 19 840682124393UDI/DI 840682124393, System ID 909558D670NM, Serial Number DDRX34058 20 840682124393UDI/DI 840682124393, System ID 215707D670, Serial Number DDRW34002 - Amount recalled
- 76 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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