Events

Recall of ASC2000 Ambulatory Surgical Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris 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
    51953
  • Event Risk Class
    Class 2
  • Event Number
    Z-1597-2009
  • Event Initiated Date
    2009-04-17
  • Event Date Posted
    2009-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81732
  • 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
    Ambulatory Surgical Table - Product Code GDC
  • Reason
    Upon investigation, the firm determined that repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.
  • Action
    A Field Correction Notice dated April 17, 2009 was issued to customers. The letter described the potential problem of the unit. The letter also notified customers of the corrective actions to be taken by the firm. A Steris technician will visit affected accounts to inspect the hydraulic hoses and replace any that show abrasion and will make other preventive corrections. For further information or if you have questions regarding the servicing of your unit, please contact the STERIS Field Service Dispatch at 1-800-288-2805.

Device

ASC2000 Ambulatory Surgical Table
  • Model / Serial
    All serial numbers.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA and WV), AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ECUADOR, GERMANY, HONG KONG, INDIA, INDONESIA, ITALY, KOREA, MEXICO, PHILIPPINES, PORTUGAL, SINGAPORE, SPAIN, SRI LANKA and THAILAND.
  • Product Description
    ASC2000 Ambulatory Surgical Table. Model #MTS110003. || The device is used to provide complete and flexible positioning for surgical procedures.
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Manufacturer Address
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060
  • Source
    USFDA