GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) 5178728: UDI/DI N/A, System ID YN1200, Serial Number: 16179; System ID YN1650, Serial Number: 17339. 2) H3000WE: UDI/DI N/A, System ID 82426060010, Serial Number Not Available; System ID 82426080021, Serial Number Not Available; System ID 82426090035, Serial Number 18605; System ID 82426090037, Serial Number 18604; System ID 82426100057, Serial Number 19191; System ID 82426150036, Serial Number 18624; System ID 82426150038, Serial Number Not Available; System ID 82426180015, Serial Number 18611; System ID 082426010021, Serial Number 18644; System ID 082426030032, Serial Number 18627; System ID 082426050012, Serial Number 18629; System ID 082426070041, Serial Number 18639; System ID 082426090044, Serial Number 18652; System ID 082426100067, Serial Number 18648; System ID 082426100069, Serial Number 18641; System ID 082426120031, Serial Number 18656; System ID 082426120033, Serial Number 18650; System ID 082426140029, Serial Number 18628; System ID 082426140030, Serial Number 18647; System ID 082426150039, Serial Number 18651; System ID 082426150040, Serial Number 18657; System ID 082426160040, Serial Number 18442; System ID 082426160054, Serial Number 18645; System ID 082426170004, Serial Number 18649; System ID 082426190031, Serial Number 18646; System ID 082426210028, Serial Number 18655; System ID 082426230028, Serial Number 18653; System ID 082426250006, Serial Number 18637; System ID 671USNHINF, Serial Number 17799; System ID A5128757, Serial Number 17566; System ID 713794INF, Serial Number 17219; System ID 920794inf, Serial Number 16364. 3) H3000WM: UDI/DI N/A, System ID NM16353, Serial Number 16353; System ID YN1540, Serial Number 16335; System ID YN1555, Serial Number 16315. 4) H3000YG: UDI/DI N/A, System ID A5172908, Serial Number 16143.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Product Codes/Lot Numbers:
1) 5178728: UDI/DI N/A, System ID YN1200, Serial Number: 16179; System ID YN1650, Serial Number: 17339. 2) H3000WE: UDI/DI N/A, System ID 82426060010, Serial Number Not Available; System ID 82426080021, Serial Number Not Available; System ID 82426090035, Serial Number 18605; System ID 82426090037, Serial Number 18604; System ID 82426100057, Serial Number 19191; System ID 82426150036, Serial Number 18624; System ID 82426150038, Serial Number Not Available; System ID 82426180015, Serial Number 18611; System ID 082426010021, Serial Number 18644; System ID 082426030032, Serial Number 18627; System ID 082426050012, Serial Number 18629; System ID 082426070041, Serial Number 18639; System ID 082426090044, Serial Number 18652; System ID 082426100067, Serial Number 18648; System ID 082426100069, Serial Number 18641; System ID 082426120031, Serial Number 18656; System ID 082426120033, Serial Number 18650; System ID 082426140029, Serial Number 18628; System ID 082426140030, Serial Number 18647; System ID 082426150039, Serial Number 18651; System ID 082426150040, Serial Number 18657; System ID 082426160040, Serial Number 18442; System ID 082426160054, Serial Number 18645; System ID 082426170004, Serial Number 18649; System ID 082426190031, Serial Number 18646; System ID 082426210028, Serial Number 18655; System ID 082426230028, Serial Number 18653; System ID 082426250006, Serial Number 18637; System ID 671USNHINF, Serial Number 17799; System ID A5128757, Serial Number 17566; System ID 713794INF, Serial Number 17219; System ID 920794inf, Serial Number 16364. 3) H3000WM: UDI/DI N/A, System ID NM16353, Serial Number 16353; System ID YN1540, Serial Number 16335; System ID YN1555, Serial Number 16315. 4) H3000YG: UDI/DI N/A, System ID A5172908, Serial Number 16143.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0888-2025
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