Reported Jan 22, 2025 · Ongoing
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; 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 Hawkeye 1
- Model/Catalog Numbers1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
- Lot codes and dates
91 of 91 products
Products covered by this recall # Barcodes Product as published 1 UDI/DI N/A, System ID YN1593, Serial Number 16433. 2) H3000YM: UDI/DI N/A, System ID 602406INF, Serial Number 16012 2 UDI/DI N/A, System ID 928537INF, Serial Number 16021 3 UDI/DI N/A, System ID 661633NM1, Serial Number 15013 4 UDI/DI N/A, System ID 661633NM1, Serial Number 16051 5 UDI/DI N/A, System ID 619482INFINIA, Serial Number 16007 6 UDI/DI N/A, System ID 626359INF2, Serial Number 16175 7 UDI/DI N/A, System ID 626359INF1, Serial Number 16177 8 UDI/DI N/A, System ID 916983INFN1, Serial Number 16059 9 UDI/DI N/A, System ID 858554INF1, Serial Number 16169 10 UDI/DI N/A, System ID 858554INF2, Serial Number 16186 11 UDI/DI N/A, System ID 626570INF1, Serial Number 16030 12 UDI/DI N/A, System ID 310543INF1, Serial Number 16006 13 UDI/DI N/A, System ID 303320IH, Serial Number 16013 14 UDI/DI N/A, System ID 860350INIF, Serial Number 16065 15 UDI/DI N/A, System ID 863687INF1, Serial Number 16182 16 UDI/DI N/A, System ID 941629INF, Serial Number 16026 17 UDI/DI N/A, System ID 630801INF, Serial Number 16054 18 UDI/DI N/A, System ID 316962WI, Serial Number 16048 19 UDI/DI N/A, System ID 270651INF1, Serial Number 16002 20 UDI/DI N/A, System ID 225765INF1, Serial Number 16070 - Amount recalled
- 93 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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