Events

Recall of Device Recall Siemens MULTIX FUSION

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
    67568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1505-2014
  • Event Initiated Date
    2014-02-13
  • Event Date Posted
    2014-04-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125728
  • 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, stationary - Product Code KPR
  • Reason
    It was observed that the corrugated hose holder above the 3d rail on the multix fusion system became loose. according to the installation instructions the corrugated hose holder shall be afixed with transversal carriage, with loctite 243 and torque 10nm during system installation. siemens initiated the update instruction to verify and secure the hose holder with loctite 243. a pcb d802 rev. 00 b.
  • Action
    Affected customers were initially notified with a recall letter on/about 2/12/14 and were sent Update Instructions to affected customers.

Device

Device Recall Siemens MULTIX FUSION
  • Model / Serial
    model nos. 10746665, 10746666, 10847610, 10746700
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
  • Product Description
    MULTIX FUSION. || The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA