Class II SCC Soft Computer

Company: SCC Soft Computer,
Date of Enforcement Report:8/2/2006
Class:lI

PRODUCT
SoftPath ASXII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinical documentation and data processing, Recall # Z-1243-06

REASON
Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.

CODE
Software Releases 2.3.0 and 4.3.7

RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Palm Harbor, FL, by letter on October 27, 2004. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
4 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

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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

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