Z-2071-2014Class III

Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending...

Name: Z-2071-2014 Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2014-05-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-05-22 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and... on 2014-05-22. FDA classified it as Class III and gives the reason as "RAPIDComm 5.0 Screen Layout will display incorrect test names". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2071-2014
Classification: Class III
Status: Terminated
Initiated: 2014-05-22
Posted: 2014-07-17
Terminated: 2015-05-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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,
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: RAPIDComm 5.0 Screen Layout will display incorrect test names
Root cause tag: software
FDA 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 has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions please call (781) 269-3000.
Quantity in commerce: 6 systems
Distribution: Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.
Product codes and lots: Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2071-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2071-2014	Class III	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)