Maxxus, System, Tomography, Computed, Emission

GE HealthCare is recalling certain older Nuclear Medicine MAXXUS Computed Emission Tomography systems that may have been moved without proper support, which could damage the detector mounting mechanisms and potentially cause the detector to fall. No injuries or detector falls have been reported so far. This recall affects systems that are no longer under GE's guaranteed service period.

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Product

MAXXUS, 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...

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2025-12-10

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/f89f3a06-b18b-431e-b265-f08dcb6ef0d2