FDA Medical devices recall ·
GE Healthcare Discovery NM/CT 670, Model recall
- Recall number
- Z-0891-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Ge Medical Systems Israel, Functional Imaging
4, Hayozma St, Tirat Carmel, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 859 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) 5376204-70-54-2: UDI/DI N/A, System ID NT1030, Serial Number T27G16017/ 133897HL9; UDI/DI N/A, System ID NT4004, Serial Number T27G15008/ 128542HL8; UDI/DI N/A, System ID NT4008, Serial Number T27G16019/ 134674HL1; UDI/DI N/A, System ID NT4007, Serial Number T27G16018/ 134286HL4; UDI/DI N/A, System ID NT4009, Serial Number T27G16016/ 133646HL0; UDI/DI N/A, System ID NT1021, Serial Number T27G1700031/ 147750HL4; UDI/DI N/A, System ID NT4010, Serial Number T27G16020/ 134675HL8; UDI/DI N/A, System ID NT4012, Serial Number T27G1700032/ 148489HL8; UDI/DI N/A, System ID NT4001, Serial Number T27G15002/ 122818HL8; UDI/DI N/A, System ID NT4006, Serial Number T27G15013/ 131436HL8; UDI/DI N/A, System ID NT4002, Serial Number T27G15003/ 124423HL5; UDI/DI N/A, System ID NT4013, Serial Number T27G1700035/ 151334HL0. 2) H2401BC: UDI/DI N/A, System ID 83163862277, Serial Number T2EG1700003/153301HL7; UDI/DI N/A, System ID 83103685384, Serial Number T2AG13029/141BH2; UDI/DI N/A, System ID 83095572309, Serial Number T2AG13023/132BH1; UDI/DI N/A, System ID 83095060278, Serial Number T2AG13025/100091HL8; UDI/DI N/A, System ID 83154010867, Serial Number T2EG1600002/0; UDI/DI N/A, System ID 83091096402, Serial Number T2DG13001/133BH9; UDI/DI N/A, System ID 0910265076, Serial Number T2AG12006/86884HL4; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12010/103BH2; UDI/DI N/A, System ID 0910263259, Serial Number T2AG12014/103BH2; UDI/DI N/A, System ID NT1014, Serial Number T2AG13024/134BH7; U
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0891-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.