Events

Recall of Device Recall XCel MB700 A/C

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by X-Cel X-Ray Corp.

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
    25571
  • Event Risk Class
    Class 2
  • Event Number
    Z-0424-03
  • Event Initiated Date
    2002-11-12
  • Event Date Posted
    2003-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26078
  • 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 KPR--
  • Reason
    The x-ray system contained a defective x-ray tube shield.
  • Action
    Recalled by telephone call on 11/19/2002, with follow-up visits and letters dated 2/27/03. The tube shields were replaced and the x-ray units were recertified.

Device

Device Recall XCel MB700 A/C
  • Model / Serial
    Model MB-700 A/C, srial numbers 622686, 622687, 622688, 622689, 320367, 325120
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Northbrook, IL and Frankfort, IL
  • Product Description
    X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012
  • Manufacturer
    X-Cel X-Ray Corp

Manufacturer

X-Cel X-Ray Corp
  • Manufacturer Address
    X-Cel X-Ray Corp, 4220 Waller Drive, Crystal Lake IL 60012-2848
  • Source
    USFDA