Recall
FDAHealthDecember 10, 2025

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING — SMV DSX New Line, System, Tomography, Computed, Emission

⚠️ 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.

Is this relevant to me?

Geography
US
Source agency
FDA
Category
Health
Published
December 10, 2025

US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

What's affected?

Product
SMV DSX New Line, System, Tomography, Computed, Emission
Lot code
UDI/DI Not applicable: All serial numbers in distribution

Additional details

UDI/DI Not applicable: All serial numbers in distribution

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 7 units.

View original FDA notice →

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