FDA tracks Park gamma camera failure

Article

The perils of buying expensive capital medical equipment from companies in poor financial health were brought into focus last month after the Food and Drug Administration announced the failure of a gamma camera manufactured by Park Medical Systems, which

The perils of buying expensive capital medical equipment from companies in poor financial health were brought into focus last month after the Food and Drug Administration announced the failure of a gamma camera manufactured by Park Medical Systems, which went out of business last year.

According to the FDA, a stainless steel plate from a harmonic drive motor on an Isocam II camera failed, causing an arm of the dual-head system to fall into the gantry housing of the device. No collimator was on the camera at the time and no patient or operator was injured.

Adverse events such as the Isocam II failure are usually reported to the device manufacturer, but since Park filed for bankruptcy last year, the FDA is advising owners of Park systems to report any adverse events due to device malfunction to the agency itself. The FDA is also asking owners of Park systems to notify the agency so it can forward new information to Park users. The FDA's contact on the Park issue is Paula Simenauer, who can be reached by fax at 301/594-2968 or by e-mail at pzs@cdrh.fda.gov.

Park filed for bankruptcy in July after struggling to stay afloat for much of 1997 (SCAN 8/6/97), and the status of much of the company's installed base regarding service and maintenance issues is unknown. At least one Park facility, however, Cedars-Sinai Medical Center in Los Angeles, is using the multivendor service operations of ADAC Laboratories to maintain its system. Cedars-Sinai signed on with ADAC six months ago, according to a hospital spokesperson.

Recent Videos
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
What New Research Reveals About the Impact of AI and DBT Screening: An Interview with Manisha Bahl, MD
Can AI Assessment of Longitudinal MRI Scans Improve Prediction for Pediatric Glioma Recurrence?
A Closer Look at MRI-Guided Adaptive Radiotherapy for Monitoring and Treating Glioblastomas
Incorporating CT Colonography into Radiology Practice
What New Research Reveals About Computed Tomography and Radiation-Induced Cancer Risk
What New Interventional Radiology Research Reveals About Treatment for Breast Cancer Liver Metastases
New Mammography Studies Assess Image-Based AI Risk Models and Breast Arterial Calcification Detection
Can Deep Learning Provide a CT-Less Alternative for Attenuation Compensation with SPECT MPI?
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Related Content
© 2025 MJH Life Sciences

All rights reserved.