Recall Z-1585-2013 ยท JQP Calculator/Data Processing Module, For Clinical Use
GE Healthcare It
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mai
| Date | Jun 24, 2013 (initiated Nov 20, 2012) |
| Status | Terminated |
| Reason | If environment variables MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE are set to different values, in Microbiology result entry when released results (Final Report released) are changed and the Corrected Result messages are edited on the free-text form, some of the originally entered panel free-text is lost. For this issue to occur the original result must be amended and the environmental variabl |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated November 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Software correction is available. Please contact your GE service representative to request or install this update. Please contact your GE Service Representative with any question regarding this issue. For other questions please contact GE Helpdesk. Help Desk: North America: 1-888-778-3375 Help Desk: Europe: + 44 1603 877595 Help Desk: Asia Pacific + 61 3 5327 4000 |
| Quantity | 9 Units |
| Distribution | Worldwide Distribution - US Distribution including the states of OH, NY, GA, TX, TN and MN and the countries of Australia, Qatar and England |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.