FDA Medical devices recall ·
GE Healthcare Brivo NM 615, Model recall
- Recall number
- Z-0889-2025
- 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
- 116 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; 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) 5376204-15: UDI/DI 00840682145503, System ID 502629NMGD, Serial Number NT2UG2100002BH; UDI/DI 00840682117869, System ID 509455BRIVO, Serial Number NT24G1700010BH, UDI/DI N/A, System ID 248544D630, Serial Number NT2QG1900003BH\NT2UG2100001BH. 2) H2401MA: UDI/DI Not Available, System ID 501552D615, Serial Number NT24G1600023; UDI/DI Not Available, System ID 100035454149, Serial Number T2CG15015/100035454149; UDI/DI Not Available, System ID 337643NM, Serial Number NT24G1600021; UDI/DI Not Available, System ID 718963B615, Serial Number NT24G1700009; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1600020; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1700010; UDI/DI Not Available, System ID 509455BRIVO, Serial Number NT24G1800001; UDI/DI (01)00840682117869(11)17060021NT24G1700003BH, System ID NM6583AR, Serial Number NT24G1700003; UDI/DI (01)00840682117869(11)17090021NT24G1700006BH, System ID NT24G1700006BH, Serial Number NT24G1700006; UDI/DI (01)00840682117869(11)17080021NT24G1700004BH, System ID NT24G1700004BH, Serial Number NT24G1700004; UDI/DI Not Available, System ID Not Available, Serial Number NT24G1700008; UDI/DI Not Available, System ID CS1052NM10, Serial Number T2CG15010/166BH9; UDI/DI Not Available, System ID DK1043NM01, Serial Number T2CG15009/163BH6; UDI/DI Not Available, System ID EG2559NM01, Serial Number NT24G1700001; UDI/DI Not Available, System ID M4143529, Serial Number T2CG16018/187BH5; UDI/DI Not Available, System ID 0830
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-0889-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.