FDA Medical devices recall ·
GE Healthcare Discovery NM/CT 670 DR, Model recall
- Recall number
- Z-0892-2025
- 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
- 76 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; 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) 5376204-70-56-2: UDI/DI N/A, System IDNT7007, Serial Number NT2JG1800001; UDI/DI N/A, System IDNT4014, Serial Number T2HG1700003/ 158624HL7; UDI/DI N/A, System IDNT4017, Serial Number 157120HL7; UDI/DI N/A, System IDNT7001, Serial Number 156620HL7; UDI/DI N/A, System IDNT7005, Serial Number 159731HL9. 2) H2401AW: UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800004; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800005; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800006; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800007; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800008; UDI/DI 840682140898, System ID N/A, Serial Number NT2JG1800009; UDI/DI 840682140898, System ID LY1198CT02, Serial Number NT2JG1800010; UDI/DI N/A, System ID N/A, Serial Number T2HG1700001; UDI/DI N/A, System ID N/A, Serial Number T2HG1700002; UDI/DI N/A, System ID N/A, Serial Number T2HG1800004; UDI/DI N/A, System ID N/A, Serial Number T2HG1800001; UDI/DI N/A, System ID N/A, Serial Number T2HG1800002; UDI/DI N/A, System ID N/A, Serial Number T2HG1800003; UDI/DI N/A, System ID N/A, Serial Number T2JG1800001. 3) H3100AN: UDI/DI 840682124393, System ID 501257D670, Serial Number DDRX34049; UDI/DI 840682124393, System ID 909558D670NM, Serial Number DDRX34058; UDI/DI 840682124393, System ID 215707D670, Serial Number DDRW34002; UDI/DI 840682124393, System ID Not Available, Serial Number DDRW34004; UDI/DI 840682124393, System ID 786257NMD670, Serial Number D
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-0892-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.