CentraLink Data Management System V14 (Analyser software for in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10811600, 10811601, 10814296, 10814298, 10814877, 10814880, 10814881, 10811741, 10811742, 10811743, 10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10815474 & 10811596ARTG Number: 224615 의 리콜

Recall

RC-2014-RN-00926-1

Class II

2014-08-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00926-1

Siemens healthcare diagnostics has identified a task scheduler issue with the centralink data management system, software version 14. the issue may cause the software to stop executing commands, including uploading validated results to the lis. the issue is related to an internal software timer that overflows after 24 days. automated rules triggered by task schedulers or by actions in the centralink user interface may also be affected. the specific consequences of discontinued command execution will vary:1) automated rules will stop running. results may be released to the lis that should have been held based on the automated rules.2) tasks to upload results and download orders to/from the lis will stop running causing a delay in test processing. 3) data in memory may not be updated causing data displayed on reports to not be up to date. however, the lis information would be correct.4) a database backup may not occur when scheduled.

Siemens Healthcare Diagnostics is advising customers to log out of user sessions and restart the CentraLink services and translators as soon as it is convenient. Then periodically (more often than every 24 days) using the procedure provided to restart the CentraLink Data Management System. Siemens is currently investigating further corrective actions. This action has been closed-out on 18/08/2016.