Recall Z-1045-2026— GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Name: FDA recall Z-1045-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-10

Class II · Ongoing

Class II FDA medical device recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, initiated 2025-12-10. It names one FDA 510(k) clearance: K002553. Product: SMV DSI, System, Tomography, Computed, Emission. Reason: 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..

Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Classification: Class II
Status: Ongoing
Initiated: 2025-12-10
Firm location: Tirat Carmel, Israel

510(k) clearances named in this recall

1 on FDA's record

K002553 — DS DS I-SERIESSmv America·cleared 2000-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SMV DSI, System, Tomography, Computed, Emission

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.