FDA Issues Recall of GE Healthcare Nuclear Medicine System
On June 13, 2013, the Food and Drug Administration (FDA) issued a Class I recall for GE Healthcare’s Nuclear Medicine System—a device used to perform imaging procedures for detection of radioisotope tracer uptake in the patient’s body. It is used in a variety of fields including Oncology, Cardiology, Neurology and other diagnostic imaging applications.
The recall was initiated following a report of a patient who died due to injuries sustained after a portion of the system fell onto the patient while being scanned. After investigating the faulty equipment, GE was able to determine the incident was caused by loose bolts securing the camera to the gantry, thereby stressing the support mechanism and resulting in the incident.
The safety concern is that other machines may also contain faulty mechanisms, resulting in a potential crush hazard or entrapment if the camera falls during a patient exam. Currently, GE is recommending facilities cease use of their Nuclear Medical Systems until an inspection of the system by GE can be performed.
Recalled Nuclear Medicine System products include:
- Infinia Nuclear Medicine Systems (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)
- VG and VG Hawkeye Nuclear Medicine Systems (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 (manufactured by Elscint Ltd.)
- As well as other devices including similar mechanical concepts: Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670
If you or a loved one has suffered injury or death as a result of receiving a scan from one of the GE Healthcare Nuclear Medicine Systems listed above, our award-winning medical device attorneys would be happy to review your records to determine whether you have a viable case against GE Healthcare.