GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSX New Line

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.

SMV DSX New Line, System, Tomography, Computed, Emission

GE Healthcare began notifying their consignees by telephone on 12/10/2025, followed by an URGENT MEDICAL DEVICE CORRECTION UPDATE notice distributed on 01/05/2025 via US mail. The notice explained the issue, safety risk, and requested the consignee stop use of the product. Care should be exercised when deinstalling these systems. To discuss replacement options, your GE HealthCare account representative. Should be contacted.

• FDA enforcement recordOfficial FDA database entry for Z-1044-2026
• FDA 510(k) clearance · K894931The device's official FDA premarket clearance record
• FDA device classification · IYXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1100The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.