Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM 의 리콜

Recall

65214

Class 2

Z-0949-2014

2013-03-31

2014-02-10

Terminated

United States

2016-08-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118288

The current century break patch did not contain the same setting for the century break year for both the red hat linux and gui files. due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. this resulted in the database files meeting its maximum capacity and causing system p.

A Product Notification letter dated July 2012, was sent to Siemens Healthcare Diagnostics. The letter suggested that an attached procedure should be followed for an server that requires the Century Break parameter change. If Siemens Healthcare Diagnostics has any questions about the procedure, the firm's representatives can contact the Sysmex Technical Assistance Center at 1-888-879-7639. A response form was also included with the letter requesting the Siemens Healthcare Diagnostics complete and return it. A second Product Notification letter dated September 2012, was sent to Siemens Healthcare Diagnostics. The letter contained largely the same instructions as the July 2012, letter. A third Product Notification letter dated March 2013, was sent to Siemens Healthcare Diagnostics. The letter include substantially similar instructions as the pervious letters; however, the procedure for changing the Century Break parameter was expanded.