Day

November 1, 2006
CompanyGuidant Corporation Date of Enforcement Report:11/1/2006 Class:ll PRODUCT Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007 REASON Final software load did not occur prior to shipment of select programmers. CODE Serial numbers: 051089, 051449, 055130, 056463,...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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