Events

Recall of Sedecal Optima URS

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
    26111
  • Event Risk Class
    Class 2
  • Event Number
    Z-0652-03
  • Event Date Posted
    2003-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27098
  • 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
    unknown device name - Product Code KPR--
  • Reason
    Incorrect identification labels and their dertification testing program faialed in noncompliance with u.S. federal performance standards.
  • Action
    Sedecal USA sent end user notification letters dated 9/24/02 to the consignees having the affected Sedecal Stationary X-Ray Systems, informing them that the units do not meet with the U.S. federal performance standards, that the labels are in Spanish and that the labels may not be visible after system installation. Sedecal schedule an appointment to conduct performance tests on the mobile x-ray systems to verify their compliance with the federal performance standard, submit the data to FDA, and place the English labels on the units. Sedecal will reimburse the owners for any out-of-pocket expenses incurred. Sedecal requested the accounts to call 800-920-9525 if they had any questions, and to inform Sedecal if they sold the unit, destroyed the unit or otherwise no longer had the unit in their possession.

Device

Sedecal Optima URS
  • Model / Serial
    serial numbers G14698, G14689, G14501, G14932, G14835
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    New York, Texas, Florida and Minnesota.
  • Product Description
    Optima URS 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
  • Source
    USFDA