Reported Jan 22, 2025 · Ongoing
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography,…
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 Infinia I
- Model/Catalog Numbers1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
- Lot codes and dates
35 of 35 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID YN1200, Serial Number: 16179 2 System ID YN1650, Serial Number: 17339. 2) H3000WE: UDI/DI N/A, System ID 82426060010, Serial Number Not Available 3 System ID 82426080021, Serial Number Not Available 4 System ID 82426090035, Serial Number 18605 5 System ID 82426090037, Serial Number 18604 6 System ID 82426100057, Serial Number 19191 7 System ID 82426150036, Serial Number 18624 8 System ID 82426150038, Serial Number Not Available 9 System ID 82426180015, Serial Number 18611 10 082426010021System ID 082426010021, Serial Number 18644 11 082426030032System ID 082426030032, Serial Number 18627 12 082426050012System ID 082426050012, Serial Number 18629 13 082426070041System ID 082426070041, Serial Number 18639 14 082426090044System ID 082426090044, Serial Number 18652 15 082426100067System ID 082426100067, Serial Number 18648 16 082426100069System ID 082426100069, Serial Number 18641 17 082426120031System ID 082426120031, Serial Number 18656 18 082426120033System ID 082426120033, Serial Number 18650 19 082426140029System ID 082426140029, Serial Number 18628 20 082426140030System ID 082426140030, Serial Number 18647 - Amount recalled
- 36 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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