PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 22, 2025 Initiated: December 18, 2024 #Z-0895-2025

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.

Details

Units Affected
8 units
Distribution
Worldwide
Location
Tirat Carmel

Frequently Asked Questions

What product was recalled?
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission. Recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING. Units affected: 8 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0895-2025.