Events

Recall of Device Recall Primus Linear Accelerator 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
    45991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0850-2008
  • Event Initiated Date
    2007-07-27
  • Event Date Posted
    2008-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66636
  • 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
    Linear Accelerator System - Product Code IYE
  • Reason
    Door hinge failures; loose or falling off (stationary structure doors).
  • Action
    Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.

Device

Device Recall Primus Linear Accelerator System
  • Model / Serial
    All Serial Numbers up to Serial Number: 3532
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tennessee, Arizona, Pennsylvania, Virginia, New Jersey, Michigan, Wisconsin, Indiana, Nebraska, Montana, Kansas, Mississippi, Rhode Island, Washington, South Carolina, Maryland, New Hampshire, Maine, Arkansas, Idaho, Missouri, Louisiana, Oklahoma, North Dakota, Minnesota, Massachusetts, and The District of Columbia and countries of Canada and Mexico.
  • Product Description
    Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA
  • 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