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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens Healthcare

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  Class 3 Device Recall Siemens Healthcare see related information
Date Initiated by Firm May 22, 2014
Date Posted July 17, 2014
Recall Status1 Terminated 3 on May 26, 2015
Recall Number Z-2071-2014
Recall Event ID 68353
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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,
Code Information Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Drive
Norwood MA 02062
For Additional Information Contact
781-269-3000
Manufacturer Reason
for Recall		 RAPIDComm¿ 5.0 Screen Layout will display incorrect test names
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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