Feature | July 29, 2013

Patient's death from falling scanner component spurs total safety recall

GE Healthcare Recalls Many of its Nuclear Imaging Systems

July 29, 2013 — GE Healthcare has initiated a Class I recall of most of its SPECT nuclear imaging systems and called for its systems to not be operated until the vendor can inspect the scanner. The recall follows the death of a patient after a portion of the scanner fell onto them during the scan on an Infinia Hawkeye 4 system at a VA medical center facility in New York.

On June 17, GE sent an urgent medical device correction letter to all affected customers. The letter identified the affected product, and recommended that qualified service personnel maintain the equipment and that preventative maintenance procedures are executed according to labeling. In addition, users were told that safety chapter sections should be re-reviewed with personnel to ensure proper operation of the equipment.

On July 3, GE notified hospitals again via an urgent medical device recall letter and follow-up telephone calls, notifying that it was recalling several more of its nuclear imaging systems. The company said serious injuries or death could occur due to the failure mode associated with the recall. In the second notification, GE included most of its nuclear medicine systems, including 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 are instructed to cease use of the above mentioned nuclear imaging systems until a GE Healthcare field engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost. GE Healthcare representatives will contact hospitals to arrange for the inspection. If an issue with the support mechanism fasteners is found on a system, the GE field engineer will coordinate the replacement of impacted parts in the gantry to ensure the system is operating safely and meets all specifications.

The weight of nuclear imaging cameras is around 1,300 pounds due to the cameras being lead lined and additional lead in the construction of the internal collimation system.  This significant weight poses design challenges in these systems because of the fatigue on the supports. This is an issue faced by all vendors' system and is not unique to GE. 
 

Investigation of the Accident

In its July 3 recall letter, GE said it was informed of the patient’s death on June 5. GE Healthcare responded and is working 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.

Because of the similarities in the design of support mechanisms across many GE products, the company included in its June 17 recall all types and manufacturing dates of Infinia and Infinia Hawkeye nuclear medicine systems; all types and manufacturing dates of VG and VG Hawkeye nuclear medicine systems; and all types and manufacturing dates of Helix nuclear medicine systems by Elscint Ltd. In the July 3 letter the company expanded this recall to include the Brivo NM615, Discovery NM630, Optima NM/CT640 and the Discovery NM/CT670 due to similarities in basic mechanical concepts between these devices and the Infinia systems.

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

GE Healthcare representatives are contacting all known medical facilities that have a GE system to arrange for an inspection. For questions about this recall, contact your GE Healthcare service representative at (800) 437-1171.??

Read the July 3 recall letter here.


Related Content

News | Prostate Cancer

July 30, 2024 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization ...

Time July 30, 2024
arrow
News | Radiopharmaceuticals and Tracers

July 25, 2024 — NorthStar Medical Radioisotopes, LLC and BWXT Medical Ltd., a subsidiary of BWX Technologies, Inc ...

Time July 25, 2024
arrow
News | PET-CT

July 25, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET & PET-CT imaging ...

Time July 25, 2024
arrow
News | PET-CT

July 16, 2024 — A new research paper was published in Oncotarget's Volume 15 on June 20, 2024, titled, “Comparison of ...

Time July 16, 2024
arrow
News | Prostate Cancer

July 2, 2024 — A new editorial paper was published in Oncoscience (Volume 11) on May 20, 2024, entitled, “Deep learning ...

Time July 02, 2024
arrow
News | ASTRO

June 21, 2024 — The American Society for Radiation Oncology (ASTRO) announced today that following a nationwide search ...

Time June 21, 2024
arrow
News | Nuclear Imaging

June 20, 2024 — GE HealthCare joined the world’s top medical and academic institutions at the Society of Nuclear ...

Time June 20, 2024
arrow
News | PET Imaging

June 18, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT ...

Time June 18, 2024
arrow
News | Proton Therapy

June 14, 2024 — Atlantic Health System, an integrated health care system setting standards for quality health care in ...

Time June 14, 2024
arrow
News | PET Imaging

June 14, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT ...

Time June 14, 2024
arrow
Subscribe Now