FDA Medical devices recall ·
GE Healthcare Discovery NM/CT 670 PRO, Model recall
- Recall number
- Z-0893-2025
- 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
- 283 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; 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 NT4011, Serial Number 131640HL5; UDI/DI N/A, System ID NT1023, Serial Number 154472HL5; UDI/DI N/A, System ID NT4003, Serial Number 128062HL7; UDI/DI N/A, System ID NT4005, Serial Number 128536HL0; UDI/DI N/A, System ID NT1022, Serial Number 154066HL5. 2) H2401AK: UDI/DI N/A, System ID 83131625480, Serial Number T27G15012/131277HL6; UDI/DI N/A, System ID 83119512125, Serial Number T2AG14038/0; UDI/DI N/A, System ID 83151204341, Serial Number T27G1600025/0; UDI/DI N/A, System ID 83153611901, Serial Number T27G1700030/147506HL0; UDI/DI N/A, System ID 83136989873, Serial Number T27G15006/GLX-TAN-03716; UDI/DI N/A, System ID 83114701360, Serial Number T2AG14036/112879HL2; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700034/150126HL1; UDI/DI N/A, System ID 83162990276, Serial Number T27G1700033/150126HL1; UDI/DI N/A, System ID Not Available, Serial Number T27G15005/126820HL0; UDI/DI N/A, System ID 600002NM01, Serial Number T27G15004/126534HL7; UDI/DI N/A, System ID 083026806832815, Serial Number T2AG14035/148BH7; UDI/DI N/A, System ID Not Available, Serial Number T2AG14037/112809HL9; UDI/DI N/A, System ID 0835260017, Serial Number T2AG14039/115651HL2; UDI/DI N/A, System ID 5512MI0001, Serial Number T27G15011/130994HL7; UDI/DI N/A, System ID NT5002, Serial Number T27G16021/136626HL9; UDI/DI N/A, System ID NT5003, Serial Number T27G16023/ ; UDI/DI N/A, System ID Not Available, Serial Number T27G16022/137922HL1; UDI/DI N/A, System ID
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-0893-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.