Philips gets FDA warning letter

Philips Medical Systems North America of Shelton, CT, is responding to a warning letter from the Food and Drug Administration regarding its Integris 3000 family of vascular imaging and interventional x-ray systems. The letter claims that when the systems are connected with a VCR, the high fluoroscopy mode may not fully comply with the fluoroscopic recording provisions of FDA regulations. Philips is investigating the letter's claims and plans to issue a corrective action. In the meantime, Integris 3000 users should make sure that the VCR is recording prior to using the high fluoroscopy mode, according to the company. Philips said that the letter does not affect its newer Integris 5000 products.