Patient Death Leads to GE Nuclear Medicine Systems Recall

General Electric pulled a number of nuclear medicine imaging devices off the market after part of one of the systems fell and killed a patient.  

GE sent out a letter (PDF) to hospitals earlier this month notifying customers of the incident and warning facilities to stop using the devices.

On July 29, the FDA determined that the letter is considered a General Electric Nuclear Medicine Systems recall and that the action has been categorized as a class I medical device recall, the most serious classification.

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The one death associated with the imaging devices occurred at a Veterans Administration medical center in June. The unidentified patient was being scanned by an Infinia Hawkeye 4 Nuclear Medicine Systsem when part of it fell, causing fatal injuries.

GE investigators found that bolts securing the camera to its gantry were loose. The company warns that this design was used on a number of nuclear medicine systems, all of which could have the potential for parts to fall and injure a patient.

The recalled GE nuclear medicine systems include the Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670. Models affected by the recall include the Infinia 3/8, Infinia-II 3/8, Infinia VC, Infinia II VC, Infinia 3/8 Hawkeye, Infinia VC Hawkeye, Infinia II 3/8 Hawkeye, Infinia II VC Hawkeye, Infinia II 3/8 HE4, Infinia II 5/8 HE4, Infinia II VC HE4, Varicam, Millennium VG 3/8, Millennium VG 5/8, Millennium VG 3/8 Hawkeye, Millennium VG 5/8 Hawkeye, Discovery VH, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670. The recalled systems were distributed between October 1992 through June 2013.

On July 3, GE notified its customers of the incident and recall, indicating that it plans to send technicians out to inspect the systems. If a problem is found the system will be repaired at no cost. Customers with questions can call a GE Healthcare Service Representative at (800) 437-1171.


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