Events

Recall of Device Recall Cmax 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
    37349
  • Event Risk Class
    Class 2
  • Event Number
    Z-0554-2007
  • Event Initiated Date
    2007-02-06
  • Event Date Posted
    2007-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50396
  • 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 GDC
  • Reason
    A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.
  • Action
    A certified letter was sent to all affected consignees on February 6, 2007 notifying them of the issue and informing them of the recall and the replacement of the affected tables with new tables.

Device

Device Recall Cmax Surgical Table
  • Model / Serial
    Serial Numbers: C429106030 through C436306020
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA and Canada
  • Product Description
    Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 2720 Gunter Park Drive East, Montgomery AL 36109-1410
  • Source
    USFDA