Events

Recall of Device Recall Siemens syngo(R) Lab Data Manager

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
    62403
  • Event Risk Class
    Class 2
  • Event Number
    Z-2173-2012
  • Event Initiated Date
    2012-06-07
  • Event Date Posted
    2012-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110419
  • 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
    Software, transmission and storage, patient data - Product Code NSX
  • Reason
    The recalling firm has discovered that when using a sysmex(r) ca-7000 or ca-1500 coagulation analyzer with the syngo lab data manager (ldm), there is a potential for the syngo ldm system, to display and transmit to the lis an incorrect result following the syngo ldm's application of the configured result number format. the problem is encountered when the result number format configured on the sys.
  • Action
    Siemens Healtcare Diagnostics sent a Urgent Field Safety Notice dated June 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to discuss the contents of this letter with your Laboratory Director regarding the need to review any previous test results. If you have any technical questions or concerns, please contact the Seimens Technical Solutions Center at 1-800-441-9250, for further assistance.

Device

Device Recall Siemens syngo(R) Lab Data Manager
  • Model / Serial
    Version VA11B and all previously released versions.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
  • Product Description
    Siemens syngo(R) Lab Data Manager. || The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA