Events

Recall of Skytron EZ Slide Operating Table

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
    74128
  • Event Risk Class
    Class 2
  • Event Number
    Z-1844-2016
  • Event Initiated Date
    2016-04-06
  • Event Date Posted
    2016-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146394
  • 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
    Table, operating-room, electrical - Product Code GDC
  • Reason
    The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. if a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.
  • Action
    Skytron sent an Urgent Medical Device Recall letter dated A,pril 4, 2016, to all affected customers. On April 6, 2016, URGENT: Medical Device Recall notifications were sent to the affected hospitals and distributors via certified mail. The notification instructed the hospital to identify and remove the affected product from use. The notification instructs the distributor to contact the hospital to schedule replacement. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. The notification did not include instructions for responding to the formal recall notification, however the company did request acknowledgement via follow-up email. Please call Technical Services, at 616-656-1187 or 616-656-6403 with any questions. For after-hours support, please call 1-800-SKYTRON.

Device

Skytron EZ Slide Operating Table
  • Model / Serial
    Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.
  • Product Description
    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide || General Purpose Surgical Table || Skytron EZ Slide Operating Table || General Purpose Surgical Table
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Manufacturer Address
    Skytron, Div. The KMW Group, Inc, 5085 Corporate Exchange Blvd SE, Grand Rapids MI 49512-5515
  • Manufacturer Parent Company (2017)
    The Kmw Group Inc
  • Source
    USFDA