GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, ...
FDA Recall #Z-0895-2025 — Class II — December 18, 2024
Product Description
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Reason for Recall
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.
Recalling Firm
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — Tirat Carmel
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 units
Distribution
Worldwide
Code Information
1) H3906AB: UDI/DI 840682121446, System ID UX2305NU03, Serial Number CZTV29005; UDI/DI 840682121446, System ID M4166103, Serial Number CZTV29006; UDI/DI 840682121446, System ID 00243NUC22, Serial Number CZTW29008; UDI/DI 840682121446, System ID 00222NUC07, Serial Number CZTW29009; UDI/DI N/A, System ID 604875D670B, Serial Number CZTW29007; UDI/DI N/A, System ID NT6200, Serial Number AD7W38007; UDI/DI N/A, System ID NT6201, Serial Number AD7X38017; UDI/DI N/A, System ID NT6100, Serial Number AP7W37001.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.