Events

Recall of Device Recall Amsco 3085SP Surgical Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris Corporation.

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
    54705
  • Event Risk Class
    Class 2
  • Event Number
    Z-2402-2012
  • Event Initiated Date
    2010-02-17
  • Event Date Posted
    2012-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89058
  • 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, ac-powered - Product Code FQO
  • Reason
    Customers may be storing objects on the base and/or around the column of the surgical table. this prohibited practice and misuse known by the customers can damage the override switch assembly located at the top of the column cover. depending upon the nature and severity of the damage to the electronics of the table, it is possible that the table could move without prompting by an operator .
  • Action
    Steris sent an Urgent Field Correction Notice letter dated February 17, 2010 to their customers. The letter identified the affected product, description of the problem and actions to be taken. Customers were instructed to examine their units for any structural damage. If found they are to discontinue use and arrange for a field representative to visit the facility to assess the damages and arrange for repair of the unit. For information or questions regarding STERIS visit to your facility contact STERIS Field Service Dispatch at 1-800-333-8828.

Device

Device Recall Amsco 3085SP Surgical Table
  • Model / Serial
    B420702032 to 0402110097
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.
  • Product Description
    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. || Product Usage: || Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    USFDA