Events

Recall of XTEN LED DF cupola

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MAQUET 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
    53499
  • Event Risk Class
    Class 2
  • Event Number
    Z-0188-2010
  • Event Initiated Date
    2009-10-07
  • Event Date Posted
    2009-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85651
  • 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
    Surgical Ceiling Mounted Light - Product Code FSY
  • Reason
    Several reports have been received regarding one model of spring arm (acrobat 200 series) in combination with surgical light from various manufacturers. all incidents pertain to a crack on the front joint of the acrobat arm.
  • Action
    Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.

Device

XTEN LED DF cupola
  • Model / Serial
    Part Number: 567815999.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    XTEN LED DF cupola, P/N: 567815999. || Intended to provide visible illumination for the surgical field or for the examination of the patient.
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 1140 Us Highway 22 Ste 202, Bridgewater NJ 08807-2958
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA