Events

Recall of Device Recall Mizuho OSI Trios, Table Base

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

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
    72937
  • Event Risk Class
    Class 2
  • Event Number
    Z-0792-2016
  • Event Initiated Date
    2015-12-14
  • Event Date Posted
    2016-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142535
  • 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, electrical - Product Code GDC
  • Reason
    Table bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. if the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
  • Action
    All consignees were notified by telephone and a recall letter was mailed to each facility as a follow up. Customers were asked to remove tables from operation until they were inspected by OSI service personnel.

Device

Device Recall Mizuho OSI Trios, Table Base
  • Model / Serial
    Model numbers 7803, 7803AP.  Serial numbers 228-261.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, South Africa, Japan and United Arab Emirates.
  • Product Description
    Mizuho OSI Trios, Table Base; || Voltage: 100-240V ~ 50/60 Hz || Amps: 5,0-5.0A; || Model 7803 and 7803AP || Orthopaedic: || Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
  • Manufacturer
    Mizuho OSI

Manufacturer

Mizuho OSI
  • Manufacturer Address
    Mizuho OSI, 30031 Ahern Ave, Union City CA 94587-1234
  • Source
    USFDA