FDA Medical devices recall ·
GE Healthcare Discovery NM 630, Model recall
- Recall number
- Z-0890-2025
- 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
- 704 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; 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) 5376204-30-2: UDI/DI N/A, System ID NT3058, Serial Number T2BG1600023/ 146187HL0; UDI/DI N/A, System ID NT3061, Serial Number T2BG1600029/ 147600HL1; UDI/DI N/A, System ID NT3111, Serial Number 147243HL0; UDI/DI N/A, System ID NT3072, Serial Number 151822HL4; UDI/DI N/A, System ID NT3081, Serial Number T2BG1700045/ 155928HL5; UDI/DI N/A, System ID NT3080, Serial Number T2BG1700042/ 155272HL8; UDI/DI N/A, System ID NT3098, Serial Number T2BG1700051/ 158839HL1; UDI/DI N/A, System ID NT3088, Serial Number T2BG1700048/ 157050HL6; UDI/DI N/A, System ID NT3073, Serial Number T2BG1700040/ 150067HL7; UDI/DI N/A, System ID NT3076, Serial Number 153537HL6; UDI/DI N/A, System ID NT3048, Serial Number 141262HL6; UDI/DI N/A, System ID NT3083, Serial Number T2BG1700049/ 158144HL6; UDI/DI N/A, System ID NT0003, Serial Number T2AG14033/ 108281HL7; UDI/DI N/A, System ID NT3064, Serial Number T2BG1600025/ 146380HL1; UDI/DI N/A, System ID NT3082, Serial Number T2BG1700047/ 156900HL3; UDI/DI N/A, System ID NT3057, Serial Number T2BG1600022/ 146064HL1; UDI/DI N/A, System ID NT0005, Serial Number T2AG14040/ 119081HL8; UDI/DI N/A, System ID NT3054, Serial Number T2BG1600019/ 144873HL7; UDI/DI N/A, System ID NT3070, Serial Number T2BG1600024/ 146363HL7; UDI/DI N/A, System ID NT3067, Serial Number T2BG1600031/ 148143HL1; UDI/DI N/A, System ID NT3068, Serial Number T2BG1600034/ 149490HL5; UDI/DI N/A, System ID NT3063, Serial Number T2BG1600030/ 147951HL8; UDI/DI N/A, System ID NT3062, Serial Number
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-0890-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.