Feature | September 13, 2013 | Dave Fornell

Patient Killed During Nuclear Imaging Scan

Patient’s death from falling scanner component spurs major recall

Patient Killed During Nuclear Imaging Scan and GE Healthcare initiated a Class I recall of several of its nuclear imaging systems. SPEC Scanner kills patient.

The gamma camera portion of SPECT/CT systems (the box-shaped structures mounted to the front of the CT gantry) can weigh well over 1,000 pounds.

Diagnostic imaging is generally considered safe and noninvasive, so it is extremely unusual for a patient to die from injuries received from a scanner. However, this was the case in early June when a patient was killed because a portion of a SPECT/CT scanner fell during the scan at the James J. Peters VA Medical Center in the Bronx, N.Y. 

The weight of nuclear imaging cameras is around 1,300 pounds or more due to it being lead-lined, plus additional lead used in the construction of the internal collimation system. This significant weight poses design challenges in these systems because of the fatigue on its supports. This is an issue faced by all vendors’ systems. 

In this case, it was a GE Healthcare Infinia Hawkeye 4 system, which prompted the company to initiate a Class I recall of several of its nuclear imaging systems starting in June.  The recall was expanded to most of GE’s SPECT/CT systems in July. 

Read the FDA recall notice.

In its July 3 recall letter, GE said it was informed of the patient’s death on June 5. GE Healthcare responded and worked with the facility and all appropriate government agencies to complete a thorough investigation.

The company was permitted access to the equipment on June 17. GE Healthcare determined the bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident. The safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam, the company said.

Soon after the inspection, GE issued its first recall of several of its nuclear imaging systems. However, engineers realized the similarities in the design of support mechanisms across many of GE Healthcare’s SPECT and SPECT/CT imaging systems, so a second recall letter in July expanded the recall to nearly all of GE’s nuclear imaging systems.  The recalls included the Infinia nuclear medicine systems, VG and VG Hawkeye nuclear medicine systems, Helix nuclear medicine systems, Brivo NM615, Discovery NM630, Optima NM/CT640 and the Discovery NM/CT670.

Healthcare facilities were instructed to cease use of the above mentioned nuclear imaging systems until a GE field engineer was able to do a complete inspection of the system and perform any necessary repairs at no cost. If an issue with the support mechanism fasteners was found on a system, the GE field engineer coordinated the replacement of impacted parts in the gantry to ensure the system would operate safely and met specifications.

As of Aug. 1, GE reported it had nearly completed inspections of its SPECT systems installed globally and that systems requiring repair would be returned to service shortly.  

For more information: www.fda.gov

Related Content

NorthStar Medical Radioisotopes Completes Construction on Beloit, Wis. Molybdenum-99 Processing Facility
News | Radiopharmaceuticals and Tracers | July 16, 2019
NorthStar Medical Radioisotopes LLC  announced completion of construction on its 20,000-square-foot molybdenum-99 (Mo-...
Bracco Imaging Acquires Blue Earth Diagnostics
News | Radiopharmaceuticals and Tracers | July 01, 2019
Bracco Imaging S.p.A. has signed a definitive agreement to acquire Blue Earth Diagnostics, a molecular imaging company...
DOSIsoft Receives FDA 510(k) Clearance for Planet Onco Dose Software
Technology | Information Technology | June 20, 2019
DOSIsoft announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Planet...
United Imaging Announces First U.S. Clinical Install of uMI 550 Digital PET/CT System
News | PET-CT | June 19, 2019
United Imaging announced the first U.S. clinical installation of the uMI 550 Digital positron emission tomography/...
International Working Group Releases New Multiple Myeloma Imaging Guidelines

X-ray images such as the one on the left fail to indicate many cases of advanced bone destruction caused by multiple myeloma, says the author of new guidelines on imaging for patients with myeloma and related disorders. Image courtesy of Roswell Park Comprehensive Cancer Center.

News | Computed Tomography (CT) | June 17, 2019
An International Myeloma Working Group (IMWG) has developed the first set of new recommendations in 10 years for...
A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse

Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers.

News | Magnetic Resonance Imaging (MRI) | June 07, 2019
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular...
BGN Technologies Introduces Novel Medical Imaging Radioisotope Production Method
News | Radiopharmaceuticals and Tracers | June 05, 2019
BGN Technologies, the technology transfer company of Ben-Gurion University (BGU), introduced a novel method for...
Study Explores Magnetic Nanoparticles as Bimodal Imaging Agent for PET/MRI

Image courtesy of MR Solutions.

News | PET-MRI | May 23, 2019
Researchers from Bourgogne University in Dijon, France, showed that use of superparamagnetic iron oxide nanoparticles (...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...
Blue Earth Diagnostics Expands Access to Axumin in Europe
News | Radiopharmaceuticals and Tracers | May 13, 2019
Blue Earth Diagnostics announced expanded access to the Axumin (fluciclovine (18F)) imaging agent in Europe. The first...