FDA warns GE about defective x-ray equipment
The company received the Nov. 16 letter just three weeks before the company planned to notify the FDA that it was addressing manufacturing issues identified in the previous warning letter concerning its MRI coil and breast biopsy plate operations.
On Sept. 27, FDA field tests discovered two defective devices used in a hospital near New Orleans, which were assembled at GE’s Pewaukee, Wis., facility. During the tests, the agency found that the protective barrier was not in place during the x-ray process to intercept the beam as required by federal regulation. The letter requested that GE investigate the problem. If the company determines that the defect in the x-ray equipment is caused by improper assembly or installation, it must fix the problem, or replace the defective component or device, free of charge. The agency has instructed GE to submit its investigation results on the defective x-ray equipment as well as a plan for corrective action within 15 days of receipt of the warning letter. The FDA also warned that if the company 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 from selling its products, or monetary fines up to $300,000 per violation.
GE told Health Imaging News that the initial investigation shows that the company’s service personnel addressed the issue noted with these two devices soon after the FDA field test. The company said it “takes the FDA test finding and warning letter very seriously and we are thoroughly investigating the matter.” GE added that it is fully cooperating with the agency.