Events

Recall of Mobilett XP

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
    56921
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-2011
  • Event Initiated Date
    2010-10-04
  • Event Date Posted
    2010-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94926
  • 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
    Units not equipped with protective plastic cover over electronics.
  • Action
    Siemens Medical Solutions USA, Inc issued a mandatory field update. The letter identified the product, the problem and the action to be taken by the customer. All systems that were not yet equipped with protective cover over the D972 board would be upgraded. For questions regarding this recall call (610) 448-3237.

Device

Mobilett XP
  • Model / Serial
    Model numbers 1818363 and 1818454
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI, WY AND PUERTO RICO.
  • Product Description
    Mobilett XP and Mobilett XP Hybrid, Mobile radiology device || System, x-ray, mobile
  • 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