The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
GE Healthcare Millennium Nuclear Medicine Systems (Millennium MG, Millennium MC, and Millennium MYOSIGHT)
Model/Item Numbers: NMH817, NMH816, NMH815, NMH814, NMH803, NMH802, NMH801, NMH800, NGS014, NGS012, NGS009, NGS005, NG00
Manufacturing Dates: January 1, 1997, to July 1, 2012
Distribution Dates: January 1, 1997, to September 1, 2018
Devices Recalled in the U.S.: 996
GE Healthcare’s Millennium MG, Millennium MC, and Millennium MYOSIGHT Nuclear Medicine Systems are devices used to take images of a patient’s organs (for example, the heart, lungs, or brain) or tissues to help diagnose or treat a health condition or disease. These systems are intended for use as diagnostic imaging devices which allow the user to acquire data for high-resolution, three-dimensional images.
Reason for Recall
GE Healthcare is recalling the Millennium Nuclear Medicine Systems due to an incident in which the top detector detached and fell onto the detector below it. GE Healthcare has determined that the incident was caused by an improperly functioning primary motion stopper and a missing mechanical stopper which would limit the detector’s travel beyond its limits during normal operation.
No patient injuries have been reported, although there remains a risk of potential life-threatening bodily harm if the detector were to detach and fall during a patient exam.
Who May be Affected
Hospitals and healthcare professionals using a Millennium MG, Millennium MC, or Millennium MYOSIGHT Nuclear Medicine System for patient imaging procedures.
Patients undergoing imaging procedures using a Millennium MG, Millennium MC, or Millennium MYOSIGHT Nuclear Medicine System.
Field Service Engineers servicing a Millennium MG, Millennium MC, or Millennium MYOSIGHT Nuclear Medicine System.
What to Do
On September 14, 2018, GE Healthcare sent customers an “Urgent Medical Device Correction Letter”. The letter instructed customers to stop using the Millennium MG, Millennium MC, and Millennium MYOSIGHT Nuclear Medicine systems until GE Healthcare could complete a full and free inspection of all systems. On November 6, GE Healthcare reported they had completed inspections on all Millennium MG, Millennium MC, and Millennium MYOSIGHT Systems and confirmed no related issues were found.
Customers who have questions or need additional information regarding this recall may contact GE Healthcare Customer Service at 1-800-437-1171.
Date Recall Initiated
September 14, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.