Events

Recall of SKYTRON 3502 EZ SLIDE SURGICAL TABLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MIZUHO 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
    13269
  • Event Risk Class
    II
  • Event Initiated Date
    2016-10-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. if a table is found to have these incorrectly manufactured parts it is possible for the table's elevation column slide cap to become detached from the elevation column. this could result in the loss of control of the table top and injury to the patient or staff.

Device

SKYTRON 3502 EZ SLIDE SURGICAL TABLE
  • Model / Serial
    Model Catalog: 3502 (Lot serial: 3502-SUT-20151-0342); Model Catalog: 3502 (Lot serial: 3502-SUT-20144-0155); Model Catalog: 3502 (Lot serial: 3502-SUT-20156-0393); Model Catalog: 3502 (Lot serial: 3502-SUT-20147-0222); Model Catalog: 3502 (Lot serial: 3502-SUT-20148-0234); Model Catalog: 3502 (Lot serial: 3502-SUT-2014Z-0313); Model Catalog: 3502 (Lot serial: 3502-SUT-20154-0362); Model Catalog: 3502 (Lot serial: 3502-SUT-20154-0361); Model Catalog: 3502 (Lot serial: 3502-SUT-20156-0392)
  • Product Description
    3502 EZ Slide Surgical Table
  • Manufacturer
    MIZUHO CORPORATION

Manufacturer

MIZUHO CORPORATION
  • Manufacturer Address
    TOKYO
  • Source
    HC