SMV DSI, System, Tomography, Computed, Emission

Recall Insight

This FDA Devices action (record #Z-1045-2026) was formally reported on January 21, 2026, with the manufacturer initiating the action on December 10, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING is listed as the recalling firm, operating out of Tirat Carmel. Federal records indicate 3 units units are affected.

The documented reason for this recall is: 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 lett… Distribution data in the federal record shows the product reached: US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.