Recall Z-1195-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
Siemens Healthcare Diagnostics, Inc.
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare Diagnostics Data Center. It supports the Siemens analyzers through delivery of applications and conn
| Date | Aug 26, 2015 |
| Status | Terminated |
| Reason | Software Issues. |
| Root cause | Device Design |
| Action | Siemens mailed an Urgent Field Safety Notice and an Urgent Field Correction Letter to affected customers on 08/26/2015 to inform them of the issue. The reason for the correction, risk to health and actions to be taken were explained in the notice. |
| Quantity | 449 systems |
| Distribution | Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.