Events

Recall of Device Recall Dimension Integrated Chemistry Systems

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
    68400
  • Event Risk Class
    Class 3
  • Event Number
    Z-2133-2014
  • Event Initiated Date
    2014-05-27
  • Event Date Posted
    2014-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127514
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    There is a misassembly issue with the photometer installed on dimension¿ integrated chemistry systems instruments. through internal investigation by siemens healthcare diagnostics has confirmed that a limited number of dimension photometers were misassembled. these photometers are performing within specifications, but may lead to a shortened life of the source lamp.
  • Action
    An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.

Device

Device Recall Dimension Integrated Chemistry Systems
  • Model / Serial
    DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    FL LA AR IA OH OH WI IL LA KS MT
  • Product Description
    Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
  • 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