Reported Jan 22, 2025 · Ongoing
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH;…
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 PRO
- Model/Catalog Numbers1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
- Lot codes and dates
279 of 279 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID NT4011, Serial Number 131640HL5 2 UDI/DI N/A, System ID NT1023, Serial Number 154472HL5 3 UDI/DI N/A, System ID NT4003, Serial Number 128062HL7 4 UDI/DI N/A, System ID NT4005, Serial Number 128536HL0 5 UDI/DI N/A, System ID NT1022, Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A, System ID 83131625480, Serial Number T27G15012/131277HL6 6 UDI/DI N/A, System ID 83119512125, Serial Number T2AG14038/0 7 UDI/DI N/A, System ID 83151204341, Serial Number T27G1600025/0 8 UDI/DI N/A, System ID 83153611901, Serial Number T27G1700030/147506HL0 9 UDI/DI N/A, System ID 83136989873, Serial Number T27G15006/GLX-TAN-03716 10 UDI/DI N/A, System ID 83114701360, Serial Number T2AG14036/112879HL2 11 UDI/DI N/A, System ID 83162990276, Serial Number T27G1700034/150126HL1 12 UDI/DI N/A, System ID 83162990276, Serial Number T27G1700033/150126HL1 13 UDI/DI N/A, System ID Not Available, Serial Number T27G15005/126820HL0 14 UDI/DI N/A, System ID 600002NM01, Serial Number T27G15004/126534HL7 15 UDI/DI N/A, System ID 083026806832815, Serial Number T2AG14035/148BH7 16 UDI/DI N/A, System ID Not Available, Serial Number T2AG14037/112809HL9 17 UDI/DI N/A, System ID 0835260017, Serial Number T2AG14039/115651HL2 18 UDI/DI N/A, System ID 5512MI0001, Serial Number T27G15011/130994HL7 19 UDI/DI N/A, System ID NT5002, Serial Number T27G16021/136626HL9 20 UDI/DI N/A, System ID NT5003, Serial Number T27G16023/ - Amount recalled
- 283 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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