Events

Recall of Accessory Head Rest for Alphastar Operating Tables

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
    49545
  • Event Risk Class
    Class 2
  • Event Number
    Z-0161-2009
  • Event Date Posted
    2008-10-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73774
  • 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
    Ac-Powered Operating-Room Table - Product Code FQO
  • Reason
    During installation or cleaning there is a risk of crushing the finger by handling the head rest in the area of the gas strut while simultaneously actuating the release lever.
  • Action
    Urgent Device Correction letters were sent beginning September 26, 2008 via Fed Ex. Letters identified the potential for finger crush in conjunction with the head rest. Proper operating instructions are provided as well as a warning sticker to be applied to the head rest indicating proper positioning. All letters included a customer response form to be completed by each institution. Information requested is: that device correction letter has been read and instructions followed; that the corrected operating instructions have been received; that the warning sticker has been properly placed on the headrest, or that they do not have the head rest identified in the device correction letter. Questions should be addressed to USA Maquet Inc at 1-888-627-8383 #1.

Device

Accessory Head Rest for Alphastar Operating Tables
  • Model / Serial
    USA Part Number 1130.67F0, No serial numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Accessory Head Rest for Alphastar Operating Tables
  • Manufacturer
    MAQUET Inc.

Manufacturer

MAQUET Inc.
  • Manufacturer Address
    MAQUET Inc., 1140 Us Highway 22 Ste 202, Bridgewater NJ 08807-2958
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA