Events

Recall of Steris 4085 series Surgical Table

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    17162
  • Event Initiated Date
    2014-08-11
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    Steris has determined there is a potential that if the surgical table feet become unlocked from the floor during a procedure, the hand control may incorrectly indicate that the table feet are locked and still contacting the floor. the user may not realize that the table is unlocked and is able to continue articulating the table using the hand control. should this occur, the table can be relocked by pressing the floor lock button on the table hand control.
  • Action
    Product to be modified

Device

Steris 4085 series Surgical Table
  • Model / Serial
    Model: Models: 4085, 4085SS and 4085 Feather Weight Leg Sction, Affected:
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    NZMMDSA