Company: Visx, Inc Date of Enforcement Report 1/30/2008 Class:ll PRODUCT Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478, Recall # Z-0365-2008 REASON Erroneous Treatment Calculations – Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software...Read More
Company: SCC Soft Computer Date of Enforcement Report 1/30/2008 Class:ll PRODUCT SoftBank II version 23.1, 23.1.1.x . , 23.1.2.x With Softscape 1.2.0.x, Recall # B-0505-08 REASON Software with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL, by Task Management Notification and telephone on September 19, 2007. Firm initiated recall is...Read More
Recipient:Omron Healthcare, Inc. Product:diagnostic and therapeutic foreign manufactured medical devices Date:1/18/2008 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...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.