Events

Recall of Device Recall Allen Medical CFlex, Polar Head Positioner Catalog Number A70700A1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allen Medical Systems, 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
    46781
  • Event Risk Class
    Class 2
  • Event Number
    Z-1478-2008
  • Event Initiated Date
    2007-11-27
  • Event Date Posted
    2008-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68247
  • 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
    Patient Position Support - Product Code CCX
  • Reason
    Handle jamming in the open position, preventing the device from adequately supporting the head during spinal surgery. possible delay in surgery, or injury.
  • Action
    Allen Medical notified accounts by telephone on 11/08/07 and the Sales Representative. The Hospitals confirmed that the device would be sent back for evaluation and upgraded.

Device

Device Recall Allen Medical CFlex, Polar Head Positioner Catalog Number A70700A1
  • Model / Serial
    Serial Numbers: A111211, A116292
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    MA, MS
  • Product Description
    Allen Medical C-Flex, Polar Head Positioner || Catalog Number: A-70700-A1 || Product is a medical device used to maintain the position of an anesthetized patient during surgery.
  • Manufacturer
    Allen Medical Systems, Inc.

Manufacturer

Allen Medical Systems, Inc.
  • Manufacturer Address
    Allen Medical Systems, Inc., One Post Office Square, Acton MA 01720
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA