Events

Recall of Alphastar

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

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
    49448
  • Event Risk Class
    Class 2
  • Event Number
    Z-0188-2009
  • Event Initiated Date
    2008-09-16
  • Event Date Posted
    2008-11-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73516
  • 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
    operating table - Product Code FQO
  • Reason
    Table tilts: the alphastar surgical table piston rod head may break and cause a full inclination of the table top during trendelenberg positioning if there is insufficient lubrication.
  • Action
    Maquet sent Recall Notification letters to all customers on September 16, 2008 by Federal Express. Letters inform customers of the potential problem with the Alphastar tables, a description of the failure and hazards involved. Hospitals are asked to confirm whether yearly maintenance by an authorized technician have been performed. If preventive maintenance has not been performed, customers are requested to contact their Maquet Service rep. A Customer Service Response form is included and customers are to complete if to acknowledge whether of not the facility is still in possession of an affected table. If so, the model number, serial number and facility name & address is to be completed so that Maquet reps can visit the facility and perform the corrective action.

Device

Alphastar
  • Model / Serial
    ALPHASTAR 1132.01AX/BX up to serial number 871; ALPHASTAR 1132.02AX/BX up to serial number 22; ALPHASTAR 1132.03AX/BX up to serial number 31.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 1140 US Highway 22, Bridgewater NJ 08807-2958
  • Source
    USFDA