Recipient: BTS S.p.A. Product: FreeEMG and PocketEMG Date: 5/10/2012 This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the...Read More
Company:Varian Medical Systems, Inc.Date of Enforcement Report 5/9/12 Class ll: PRODUCT FastPlan Treatment Planning System, Model HZ3, Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software. Recall # Z-1217-201 REASON An anomaly has been...Read More
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