Cl ll Sunquest Application Interfacing

Company:Sunquest Information Systems, Inc.
Date of Enforcement Report 10/17/12
Class ll:

PRODUCT

Sunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface. Recall Number B-2584-12

REASON
Software, with a defect or glitch, was distributed.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tuscon, AZ on 12/14/2009. Voluntary: Firm Initiated recall was terminated.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Nationwide

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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:

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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Software Verification

IEC 62366 Usability Process and Documentation

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

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