Feature | September 13, 2013 | Dave Fornell

Patient Killed During Nuclear Imaging Scan

Patient’s death from falling scanner component spurs major recall

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. 

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.  

Related Content

ASNC and SNMMI Release Joint Document on Diagnosis, Treatment of Cardiac Sarcoidosis
News | Cardiac Imaging | August 18, 2017
August 18, 2017 — The American Society of Nuclear Cardiology (ASNC) has released a joint expert consensus document wi
Houston Methodist Hospital Enters Multi-Year Technology and Research Agreement With Siemens Healthineers
News | Imaging | August 17, 2017
Houston Methodist Hospital and Siemens Healthineers have entered into a multi-year agreement to bring cutting-edge...
Study Demonstrates First Human Application of Novel PET Tracer for Prostate Cancer

Transaxial 11Csarcosine hybrid PET/CT showed a (triangulated) adenocarcinoma in the transition zone of the anterior right prostate gland on PET (A), CT (B), and a separately obtained T2?weighted MR sequence (C) with resulting PET/MRI registration (D). Image courtesy of M. Piert et al., University of Michigan, Ann Arbor, Mich.

News | Radiopharmaceuticals and Tracers | August 16, 2017
In the featured translational article in the August issue of The Journal of Nuclear Medicine, researchers at the...
PET/CT Tracer Identifies Vulnerable Lesions in Non-Small Cell Lung Cancer Patients

Example of a patient with an upper left lung NSCLC: A: FDG; B: FDG PET/CT; C: Planning radiotherapy based on FDG (66Gy) with BTVm (GTV), CTV and PTV; D: PET FMISO E: FMISO PET/CT; F: boost based on the FMISO PET (76Gy) with BTVh (biological hypoxic target volume) and PTV boost. Credit: QuantIF – LITIS EA 4108 – FR CNRS 3638, Henri Becquerel Cancer Center, Rouen, France

News | PET-CT | July 14, 2017
July 14, 2017 — Fluorine-18 (18F)-fluoromisonidazole (FMISO) is a positron emission tomography (PET)...
Novel PET Tracer Detects Small Blood Clots

PET images (MIP 0-60 min) of three Cynomolgus monkeys. Strong signals are detected at the sites where inserted catheters had roughened surfaces. Almost no other background signal is visible. Only accumulation in the gallbladder becomes visible at the bottom of the image. Credit: Piramal Imaging GmbH, Berlin Germany.

News | PET Imaging | July 07, 2017
July 7, 2017 — Blood clots in veins a
Sponsored Content | Videos | Clinical Decision Support | June 29, 2017
Rami Doukky, M.D., system chair, Division of Cardiology, professor of medicine, Cook County Health and Hospitals Syst
Dual-Agent PET/MR With Time of Flight Detects More Cancer

Tc-99m MDP bone scan (left) is negative for osseous lesions. NaF/FDG PET/MRI (right and second slide) confirms absence of bone metastases, but shows liver metastases. Image courtesy of Stanford University.

News | PET-MRI | June 20, 2017
Simultaneous injections of the radiopharmaceuticals fluorine-18 fluorodeoxyglucose (18F-FDG) and 18F-sodium fluoride (...
Combined Optical and Molecular Imaging Could Guide Breast-Conserving Surgery

WLE specimen from a patient with a grade 3, ER-/HER2-, no special type (NST) carcinoma. (A) Cerenkov image; (B) Grey-scale photographic image overlaid with Cerenkov signal. An increased signal from the tumor is visible (white arrows); mean radiance is 871 ± 131 photons/s/cm2/sr, mean TBR is 3.22. Both surgeons measured the posterior margin (outlined in blue) as 2 mm (small arrow); a cavity shaving would have been performed if the image had been available intraoperatively. The medial margin (outlined in green) measured >5 mm by both surgeons. Pathology ink prevented assessing the lateral margin; a phosphorescent signal is visible (open arrows). (C) Specimen radiography image. The absence of one surgical clip to mark the anterior margin, and the odd position of the superior margin clip (white arrow) prevented reliable margin assessment. (D) Combined histopathology image from two adjacent pathology slides on which the posterior margin (bottom of image) and part of the primary tumor are visible (open arrows). The distance from the posterior margin measured 3 mm microscopically (double arrow). The medial margin is > 5 mm (not present in image). Credit: A. D. Purushotham, M.D., King’s College London, UK

News | Nuclear Imaging | June 20, 2017
June 20, 2017 — Breast-conserving surgery (BCS) is the primary treatment for early-stage...
Overlay Init