Recall Z-2243-2012— Sunquest Information Systems, Inc.
Class III · Terminated
Class III FDA medical device recall by Sunquest Information Systems, Inc., initiated 2009-04-13, terminated 2012-08-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.. 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
- Sunquest Information Systems, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2009-04-13
- Terminated
- 2012-08-22
- Firm location
- Tucson, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.