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# FDA Says GE Millennium System Recall Class 1
- URL: https://www.fdaweb.com/fda-says-ge-millennium-system-recall-class-1/
- Published: 2018-11-15T12:00:00.000Z
- Updated: 2026-09-15T00:44:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142834

FDA [says](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm625950.htm?utm%5Fcampaign=FDA%20MedWatch%20Recall%20Notice%20-%20Millennium%20Nuclear%20Medicine%20Systems&utm%5Fmedium=email&utm%5Fsource=Eloqua) the GE Healthcare Millennium Nuclear Medicine Systems recall is Class 1\. GE says the devices are used to take images of a patient’s organs or tissues to help diagnose or treat a health condition or disease. The systems are intended for use as diagnostic imaging devices that allow users to acquire data for high-resolution, three-dimensional images, it says

GE recalled devices distributed between 1/1/97 and 9/1/18 due to an incident in which the top detector detached and fell onto the detector below it. The company says the incident was caused by an improperly functioning primary motion stopper and a missing mechanical stopper that would limit the detector’s travel beyond its limits during normal operation. No patient injuries have been reported, the company says, although there remains a risk of potential life-threatening bodily harm if the detector were to detach and fall during a patient exam.