Sunquest Encompass The reporting site is using the Encompass software in an acute patient care...
FDA Recall #Z-2243-2012 — Class III — April 13, 2009
Product Description
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
Reason for Recall
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
Sunquest Information Systems, Inc. — Tucson, AZ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
23 clients
Distribution
Worldwide distribution: USA (nationwide) and country of: Bahamas.
Code Information
versions 2.4 and later
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated