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Recall Observatory FDA recall evidence

Device product

Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.

Z-2243-2012

April 13, 2009

Class III

Product summary

Firm
Sunquest Information Systems, Inc.
Event
Event 62751
Status
Terminated
Classification
Class III
Quantity
23 clients
Official record key
device-enforcement:Z-2243-2012

Official wording

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.

Code information: versions 2.4 and later

Distribution pattern: Worldwide distribution: USA (nationwide) and country of: Bahamas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.