Events

Recall of Device Recall Siemens brand 550 TxT Patient Table

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
    56352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0166-2011
  • Event Initiated Date
    2010-03-31
  • Event Date Posted
    2010-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93284
  • 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
    Couch, radiation therapy, powered - Product Code JAI
  • Reason
    An increase in voltage may cause a short circuit of a power transistor that may cause a smoldering and smoking effect of the electrical wiring and also an unexpected lowering of the table. both issues present the potential for injury to a patient or the operator.
  • Action
    Siemens sent a Customer Information Letter on March 31, 2010, to all consignees. The letter identified the product, the problem, and the action that should be taken. Siemens implemented minor modifications to address the issues. No further action was required for the continual operation of the 550TxT Table. For questions regarding this recall call 925-602-8083.

Device

Device Recall Siemens brand 550 TxT Patient Table
  • Model / Serial
    All codes.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA
  • Product Description
    Siemens brand 550 TxT Patient Table, Part No. 7346534, Distributed by and/or Manufactured by Siemens AG, Medical Solutions, Germany
  • 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