SoftPath ASCII Software Cl Il

Company: SCC Soft Computer
Date of Enforcement Report 10/8/2008
Class:ll

PRODUCT
SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3, Recall # Z-2463-2008

REASON
In the creation of revised report and supplemental reports diagnosis, text was inserted from another case.

RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter beginning February 23, 2006. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
201 units

DISTRIBUTION
Nationwide and Canada

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

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IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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