SMV BodyTrack, System, Tomography, Computed, Emission
FDA Recall #Z-1046-2026 — Class II — December 10, 2025
Product Description
SMV BodyTrack, System, Tomography, Computed, Emission
Reason for Recall
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
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
12 units
Distribution
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
Code Information
UDI/DI Not applicable: All serial numbers in distribution
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.