Events

Recall of Device Recall Siemens Healthcare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68353
  • Event Risk Class
    Class 3
  • Event Number
    Z-2071-2014
  • Event Initiated Date
    2014-05-22
  • Event Date Posted
    2014-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127449
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Rapidcomm¿ 5.0 screen layout will display incorrect test names.
  • 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.

Device

Device Recall Siemens Healthcare
  • Model / Serial
    Serial Numbers: 4387, 3734, 4177, 4149, 3074, 4194
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of OR and PA., and the countries of Denmark and UK.
  • Product Description
    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,
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Drive, Norwood MA 02062
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA