Events

Recall of Device Recall STERIS 4805

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
    68678
  • Event Risk Class
    Class 2
  • Event Number
    Z-2026-2014
  • Event Initiated Date
    2014-06-27
  • Event Date Posted
    2014-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128438
  • 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
    Steris engineering analysis has determined the d1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. if one or more of the table floor lock feet become unlocked due to the loss of hydraulic pressure, there is a potential for the table hand control to incorrectly indicate that the floor lock feet are locked.
  • Action
    STERIS sent an Urgent Voluntary Field Correction Noticel letter dated June 27, 2014 to affected Customers.via FedEx with tracking numbers for delivery confirmation. The letter identified the description of the product, description of the problem and the actions to be taken. For questions contact Steris Field Service Dispatch at 1-800-333-8828.

Device

Device Recall STERIS 4805
  • Model / Serial
    All Model Numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide in the states of AL, AK, AZ, AR, CA,CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY in the countries of Canada, India, Vietnam, China, India, Korea, Mexico, costa Rica, Brazil, Taiwan, Australia, New Zealand, El Salvador, Indonesia, Hong Kong, Singapore, Nepal.
  • Product Description
    The STERIS 4085 General Surgical Table || Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA