Recall Z-2671-2016 ยท JQP Calculator/Data Processing Module, For Clinical Use
GE Healthcare It
Centricity Laboratory Core Lab System 4.1 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 i
| Date | Nov 20, 2012 |
| Status | Terminated |
| Reason | The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results. |
| Root cause | Software design |
| Action | GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated Nov 20, 2012 to all affected customers. The letter described the product, problems and actions to be taken. The customers were instructed to follow the safety instructions and to ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #86071. Customers were instructed to contact their GE Service Representative |
| Quantity | 17 |
| Distribution | Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.