Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1045-2026 — SMV DSI, System, Tomography, Computed, Emission

U.S. FDA — Device Enforcement · Israel · 2025-12-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1045-2026
Date of alert
2025-12-10
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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