GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Summary
The FDA issued a Class II for GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; Sys by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0894-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Lot/Code Info: 1) H3100XF: UDI/DI N/A, System ID NT1011, Serial Number T2AG12009/ 88227HL4; UDI/DI N/A, System ID NT2002, Serial Number T2AG12011/ 89154HL9; UDI/DI N/A, System ID NT1009, Serial Number T2AG12013/ 90088HL6; UDI/DI N/A, System ID NT1003, Serial Number T2BG11001/ 79573HL2; UDI/DI N/A, System ID NT1004, Serial Number T2AG12003/ 79574HL0; UDI/DI N/A, System ID NT1005, Serial Number 84775HL6; UDI/DI N/A, System ID NT1020, Serial Number T2AG12012/ 89666HL2; UDI/DI N/A, System ID NT1016, Serial Number T2AG13020/ 96237HL3; UDI/DI N/A, System ID NT0002, Serial Number 106491HL4; UDI/DI N/A, System ID NT2004, Serial Number 105724HL9; UDI/DI N/A, System ID NT1012, Serial Number T2AG13016/ 93885HL2; UDI/DI N/A, System ID NT1012, Serial Number T2AG13017/ 93885HL2; UDI/DI N/A, System ID NT1013, Serial Number 94165HL8; UDI/DI N/A, System ID NT1010, Serial Number T2AG12008/ 87697HL9; UDI/DI N/A, System ID NT3001, Serial Number 85748HL2; UDI/DI N/A, System ID NT1017, Serial Number T2AG13027/ 104213HL4; UDI/DI N/A, System ID NT1015, Serial Number T2AG13018/ 94292HL0.
Quantity Affected: 17 units
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.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-18
Company
Tirat Carmel
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING have FDA actions?
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING has 44 FDA actions in our database, including 41 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0894-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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