January 30, 2008
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...
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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...
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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...
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