Events

Recall of Siremobil IsoC

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
    33082
  • Event Risk Class
    Class 3
  • Event Number
    Z-0122-06
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2005-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41297
  • 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
    Screws may become loose and fall into the or field during surgery.
  • Action
    The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits.

Device

Siremobil IsoC
  • Model / Serial
    Model number 2829450
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped nationwide to a distributor, a physician, and medical facilities
  • Product Description
    Siremobil Iso-C Mobile X-Ray System
  • 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