Z-2243-2012 Class III Terminated
FDA device recall Z-2243-2012 was initiated by Sunquest Information Systems, Inc. on April 13, 2009 and is designated Class III. 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 T… The recall status is terminated (terminated August 22, 2012). Affected quantity: 23 clients.
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2012
- Initiation Date
- April 13, 2009
- Termination Date
- August 22, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23 clients
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.
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of: Bahamas.
Code Information
versions 2.4 and later