GE Healthcare has been warned about defective X-ray equipment by the Food & Drug Administration (FDA). According to an FDA warning letter sent to GE Healthcare on November 16, 2007, the defective devices were discovered during field tests conducted by the agency.
The FDA field tests involved two GE Healthcare X-ray devices used in a hospital near New Orleans, and assembled at the company’s Pewaukee, Wisconsin, facility. During the tests, systems were found in which the protective barrier was not in place during the X-ray process to intercept the X-ray beam as required by federal regulation. The FDA has requested that GE HealthCare investigate the problem, and if GE determines that the defect in the X-ray equipment is caused by improper assembly or installation, the company must fix the problem or replace the defective component or device free of charge. If however, GE HealthCare determines that the X-ray equipment problems originated with the factory-based manufacture , that the X-ray equipment is not defective, or that the defect does not affect the safety of the X-ray device, it must submit documentation that illustrates such findings to the FDA.
The FDA has instructed GE Healthcare to submit the results of its investigation into the defective X-ray equipment and a plan for corrective action within 15 days of receipt of the warning letter. The FDA also warned that if GE Healthcare failed to comply with the terms of the warning letter, it could be subject to penalties including seizure of product inventories, court injunctions preventing GE Healthcare from selling its products, or monetary fines up to $300,000 per violation.
The FDA issues warning letters when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products. The FDA issues dozens of warning letters each year and many are resolved without further action. In rare cases, a warning can lead to product seizures or hold up approval of new products.
GE Healthcare said it is probing the issue so that the issues with the X-ray equipment can be resolved as soon as possible.
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