Cl II SoftPath Laboratory Information System

Company:SCC Soft Computer
Date of Enforcement Report: 2/18/2015
Class lI:

PRODUCT

SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Recall Number Z-1065-2015

REASON
Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.

RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL on 11/262014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
108

DISTRIBUTION
Nationwide and Canada

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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:

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

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