Recall Z-2071-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Siemens Healthcare Diagnostics Inc
Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
| Date | Jul 17, 2014 (initiated May 22, 2014) |
| Status | Terminated |
| Reason | RAPIDComm 5.0 Screen Layout will display incorrect test names |
| Root cause | Software design |
| Action | Siemens Healthcare issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on May 22, 2014, both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the RAPIDComm Data Management System (Version 5.0.A software correction will be issued to address the problem. Please retain this letter with your laboratory records. Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. We apologize for the inconvenience this situation |
| Quantity | 6 systems |
| Distribution | Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.