Events

Recall of Skytron

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Skytron, Div. The KMW Group, 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
    35875
  • Event Risk Class
    Class 2
  • Event Number
    Z-1497-06
  • Event Initiated Date
    2005-08-04
  • Event Date Posted
    2006-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48116
  • 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 Table - Product Code FQO
  • Reason
    The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop.
  • Action
    A service bulletin was issued to distributors on 8/12/05 instructing them to identify customers and to retrofit these tables.

Device

Skytron
  • Model / Serial
    All units. Serial numbers 6600B-2D-002 through 6600B-2L-060.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Skytron General Purpose Surgical Table, battery model; Model 6600B, Dist. by Skytron, Grand Rapids, MI.
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Manufacturer Address
    Skytron, Div. The KMW Group, Inc, 5000 36th St Se, Grand Rapids MI 49512-2008
  • Source
    USFDA