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Patient Death Prompts Class I Recall of GE Nuclear Medicine Systems

Earlier this month, General Electric pulled several nuclear medicine imaging devices off the market after one system fell and killed a patient. In a July 3, 2013 letter, General Electric notified hospitals and consumers of the incident and advised medical facilities and hospitals to stop using these affected nuclear medicine system devices. In response, on July 29th, the Food and Drug Administration(FDA) designated the letter as a General Electric Nuclear Medicine Systems Recall and issued a Class I Medical Device Recall, the most serious classification, for the following General Electric Nuclear Systems: 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.

The particular models of such General Electric nuclear medicine systems affected by this Class I Medical Device Recall include the following: 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. These recalled systems and models were distributed between October 1992 and June 2013.

The death associated with these General Electric Nuclear Medicine System devices happened at a Veterans Administration medical facility in June of this year. While being scanned by an Infinia Hawkeye Nuclear Medical System, part of the system fell on a patient, causing fatal injuries to the unidentified patient. General Electric investigators subsequently found that bolts securing the camera were loose, causing the part of the system to collapse and fall on the patient. General Electric warned that it used this same design on several other nuclear medicine systems, and that therefore, all such systems have the potential for falling parts. General Electric plans to send technicians out to medical facilities and hospitals in order to personally inspect the affected systems at issue. However, in the interim, General Electric admonishes against using the systems entirely.

 

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