Cl lll Sunquest Encompass

Company:Sunquest Information Systems, Inc.
Date of Enforcement Report 8/29/12
Class lll:

PRODUCT

Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. Recall Number Z-2243-2012

REASON
Sunquest is recalling the Sunquest Encompass versions 2.4 and later because the specimen collect time is displaying and printing one hour later than the actual collect time only when Daylight Saving Time is active.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc. Tiscon, AZ on 4/13/2009. Voluntary: Firm Initiated recall has been terminated.

VOLUME OF PRODUCT IN COMMERCE
23 clients

DISTRIBUTION
Nationwide and the Bahamas

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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.

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IEC 62366 Usability Process and Documentation

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