Recall Z-2243-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
Sunquest Information Systems, Inc.
Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting.
| Date | Aug 22, 2012 (initiated Apr 13, 2009) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | The firm, Sunquest, sent a "Urgent-Product Safety Notice: PSN-09-01" letter dated April 13, 2009 all their customers who purchase the Sunquest Encompass versions 2.4 and later. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to request software correction and to create a service request via client support webpage at www.sunquestinfo.com/supportweb. Then choose Submit a Service Request. Select Issue Type and select Software Request. When Software Request is selected, the Work Queue field automatically fills in with "Software |
| Quantity | 23 clients |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.