Events

Recall of Device Recall AMATECH

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

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
    29589
  • Event Risk Class
    Class 2
  • Event Number
    Z-1327-04
  • Event Initiated Date
    2004-07-12
  • Event Date Posted
    2004-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34178
  • 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, Ac-Powered - Product Code FQO
  • Reason
    Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement.
  • Action
    Allen Medical notified the two distributors by telephone on 7/12/04 and 7/16/04. A customer notifcation letter issued requesting return of the device for correction.

Device

Device Recall AMATECH
  • Model / Serial
    131613, 131614, 131615, 131616,152144, 152145, 152147, 152148 219039, 219040, 219042, 219043, 232800, 232801, 232802, 232803, 232804, 205395, 205396, 235327, 235329, 235330, 237473, 237465, 237467, 237468, 237469, 237470, 237471
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    SC
  • Product Description
    Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table || Catalog No: MDTNA2
  • Manufacturer
    Allen Medical Systems

Manufacturer

Allen Medical Systems
  • Manufacturer Address
    Allen Medical Systems, One Post Office Square, Acton MA 01720-3934
  • Source
    USFDA