Jan

2012

Cl ll SoftReports version 1.1.8.2.4

Company:SCC Soft Computer
Date of Enforcement Report 1/11/12
Class ll:

PRODUCT
SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases. Recall # Z-0362-2012

REASON
When SoftReports Designer opened a layout, the system did not load the layout with the previously saved .

RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter dated October 25, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

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.

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Cl ll SoftReports version 1.1.8.2.4

Amy Sellers

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