Class I Recall of Millennium Nuclear Medicine Systems by GE Healthcare

PUBLISHED: Nov 15, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals

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.

Recalled Product(s):

  • 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

In their September 2018 “Urgent Medical Device Correction Letter” GE Healthcare instructed customers to stop using the Millennium MG, Millennium MC, and Millennium MYOSIGHT Nuclear Medicine systems until GE Healthcare completed 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.

The FDA has classified this a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Follow the link below for additional information.

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