Events

Recall of Device Recall Coherence Dosimetrist, v 2.2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
    54706
  • Event Risk Class
    Class 2
  • Event Number
    Z-1834-2011
  • Event Initiated Date
    2009-11-06
  • Event Date Posted
    2011-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89038
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • Reason
    A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. for the target the user defines the max. dose and the min dose, for the oar (organs at risk) the user only defines the max. dose. the firms engineering team determined that the software defect was repeatable.
  • Action
    Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.

Device

Device Recall Coherence Dosimetrist, v 2.2
  • Model / Serial
    Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.
  • Product Description
    Coherence Dosimetrist, version 2.2. || Intended use: Medical charged-particle radiation therapy system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA