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

FDA device recall Z-1044-2026 · posted 2026-01-09 · Open, Classified

Recall details

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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.

Action taken

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.

Root cause

Package design/selection

Status

Open, Classified

Product code

IYX

Quantity affected

7 units

Distribution

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

Date initiated

2025-12-10

Date posted

2026-01-09

Location

Tirat Carmel, Israel

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