Events

Recall of Device Recall Siemens Mobilett XP Digital Mobile 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
    68382
  • Event Risk Class
    Class 2
  • Event Number
    Z-1985-2014
  • Event Initiated Date
    2014-05-09
  • Event Date Posted
    2014-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127494
  • 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, mobile - Product Code IZL
  • Reason
    There is a potential fire hazard of certain lithium-ion batteries in the computers used in the original manufacturing or as spare parts between october 2010 and april 2011 for the siemens mobilett xp digital mobile x-ray system, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
  • Action
    Siemens sent a Safety Advisory Notice letter dated May 9, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that a Siemens service technician would be visiting their site to identify and service affected devices.

Device

Device Recall Siemens Mobilett XP Digital Mobile Xray System
  • Model / Serial
    model no. 1818447, with serial nos.: 3284 3449 1026 1025 1010 1041 1054 2002 2058 2022
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.
  • Product Description
    Siemens Mobilett XP Digital Mobile X-ray System || Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
  • 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