Events

Recall of Sedecal SPHF 4.0 Portable XRay System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sedecal 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
    27549
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-04
  • Event Initiated Date
    2003-10-27
  • Event Date Posted
    2003-10-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30043
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code IZL--
  • Reason
    A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the sp-hf-4.0 portable systems not complying with the u.S. federal performance standard.
  • Action
    An 'Important Safety Notice' dated 10/27/03 was sent to the one direct account on the same date, informing them of the non-compliances with the performance standard and requesting them to call Sedecal at 800-920-9525 to arrange for the modification of the x-ray unit at no cost to the user.

Device

Sedecal SPHF 4.0 Portable XRay System
  • Model / Serial
    serial #PK10058
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Vermont
  • Product Description
    Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain
  • Manufacturer
    Sedecal USA, Inc

Manufacturer

Sedecal USA, Inc
  • Manufacturer Address
    Sedecal USA, Inc, 2910 N Arlington Heights Rd, Arlington Heights IL 60004-1551
  • Source
    USFDA