GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Medical Device Recall in 2026 - (Recall #: Z-1045-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

SMV DSI, System, Tomography, Computed, Emission

Product Classification:

Class II

Date Initiated: December 10, 2025

Date Posted: January 21, 2026

Recall Number: Z-1045-2026

Event ID: 98133

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.

Status: Ongoing

Product Quantity: 3 units

Code Information:

UDI/DI Not applicable: All serial numbers in distribution

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated