Events

Recall of Device Recall Maquet Foot switch

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
    50472
  • Event Risk Class
    Class 2
  • Event Number
    Z-0620-2009
  • Event Initiated Date
    2008-12-08
  • Event Date Posted
    2009-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75452
  • 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
    Accessories, operating-room, table - Product Code FWZ
  • Reason
    A bearing point of the pedal of the foot switch may come loose. with continued use of the foot switch, one or both springs beneath the pedal can fall out of their mounting, and it is possible the pedal comes to rest on the switch causing an unintended motion of the operating table during patient use.
  • Action
    An Urgent Device Correction letter (with an enclosed Customer Response form) was sent via Federal Express on Monday, December 8, 2008 to all customers who had received tables. Customers were notified in the letter of the problem and actions to be taken including not to use any affected foot pedal for safety reasons. In addition, customers were instructed to complete and return the Customer Response Form via fax (732-667-1903) to Maquet Inc. Please call USA Maquet, Inc. at toll free number 1-888-627-8383 #1 (then select the option for Surgical Workplace products) for questions.

Device

Device Recall Maquet Foot switch
  • Model / Serial
    Product manufactued between 8/2004 and 9/2008 may be affected: 1009.81A0, 1009.81A1, 1009.81A2, 1009.81A3, 1009.81B0, 1009.81B1, 1009.81B2, 1009.81C0, 1009.81C1, 1009.81D0, 1009.81D1, 1009.81D2, 1009.81D3, 1009.81D4, 1009.81E0, 1009.81E1, 1009.81E2, 1009.81E3, 1009.81F0, 1009.81F1, 1009.81F2, 1009.81F3, 1009.81G0, 1009.81G1 and 1009.81G2.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. || The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.
  • Manufacturer
    MAQUET Inc.

Manufacturer

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