Events

Recall of Device Recall Sedecal SA Mobile Diagnost w DR 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
    74106
  • Event Risk Class
    Class 2
  • Event Number
    Z-1691-2016
  • Event Initiated Date
    2015-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146293
  • 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
    Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : normal ) even though the patient type " newborn" was selected and is displayed in the generator control area of the eleva user interface.
  • Action
    Sedecal USA has developed a new software release to address this issue. The distributor of this product, Philip, will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the two defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (847) 394-6960.

Device

Device Recall Sedecal SA Mobile Diagnost w DR xray system
  • Model / Serial
    System Code 712001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.
  • Product Description
    Sedecal SA Mobile Diagnost w DR x-ray system
  • Manufacturer
    Sedecal USA, Inc.

Manufacturer

Sedecal USA, Inc.