Events

Recall of Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A

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
    65147
  • Event Risk Class
    Class 2
  • Event Number
    Z-0433-2014
  • Event Initiated Date
    2013-05-10
  • Event Date Posted
    2013-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118015
  • 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
    Under certain conditions the system may not perform as intended, causing the release of results to the laboratory information system that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the lis.
  • Action
    Siemens sent an Urgent Medical Device Correction letter in May 2013 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the letter in its entirety and ensure that all operators understand the information presented. Specific actions needed to be implemented by the customer were outlined in the letter. Customers were instructed to retain the letter with their laboratory records, and forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.

Device

Device Recall Siemens syngo(R) Lab Data Manager Version VA11B and VA12A
  • Model / Serial
    Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (nationwide) and internationally to Canada.
  • Product Description
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems || Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA