Events

Recall of POLYSTAR T.O.P. XRay System

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
    30170
  • Event Risk Class
    Class 3
  • Event Number
    Z-0196-05
  • Event Initiated Date
    2004-09-23
  • Event Date Posted
    2004-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35303
  • 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, X-Ray, Angiographic - Product Code IZI
  • Reason
    Orbital gears may exhibit excess wear.
  • Action
    The recalling firm issued Update Instructions, AX077/04/S, to Siemen''s Customer Service Representative (CSR) to visit affected sites and check the orbital gears for excessive wear. If the CSR finds gears exhibiting excessive wear the orbital gears will be replaced. If no wear is observed the gears will be lubricated as a preventive measure.

Device

POLYSTAR T.O.P. XRay System
  • Model / Serial
    Serial Numbers for model 1148902: 01000 through 01267, 02001 through 02117. Serial numbers for model4784505: 03001 through 035158, 04001 through 04136, and 05001 through 05098
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide and government accounts in KS and MI.
  • Product Description
    POLYSTAR T.O.P., Angiographic X-Ray System, Model || Numbers 1148902 and 4784505.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA