Company: GE OEC Medical Systems, Inc. Date of Enforcement Report:10/11/2006 Class:ll PRODUCT a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, Recall # Z-1301-06; b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06; c) RUS Tool Version Software, Recall # Z-1303-06 REASON X-ray systems could provide output which exceeds the 20 R/minute...Read More
Recipient: Biolase Technology Inc.Product:Medical and dental lasers Date: 9/5/06 Design output procedures do not allow for an adequate evaluation of conformance to design input requirements as required by 21 CFR 820.30(d). Specifically, the software requirement input specifications for the Waterlase MD dental laser could not be individually verified and documented to show conformance to the...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.