GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Medical Device Recall in 2025 - (Recall #: Z-0895-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission

Product Classification:

Class II

Date Initiated: December 18, 2024

Date Posted: January 22, 2025

Recall Number: Z-0895-2025

Event ID: 96079

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.

Status: Ongoing

Product Quantity: 8 units

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.

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated