WhichRecall
Class IIReported 2026-01-21

MAXXUS, System, Tomography, Computed, Emission

Recalled by 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

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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.

Recall Number
Z-1047-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-10
Reported
2026-01-21
Distribution
US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece
Code Info
UDI/DI Not applicable: All serial numbers in distribution
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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