Events

Recall of Device Recall Allen CFlex Head Positioner

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
    60435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0655-2012
  • Event Initiated Date
    2011-11-16
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105422
  • 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
    Support, patient position - Product Code CCX
  • Reason
    C-flex polar head positioner may have an adjustment screw loosen and affect load capacity.
  • Action
    Allen Medical Systems sent a Urgent Medical Device Recall Notification dated November 18, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Allen Medical will provide packaging materials and instructions for returning your device for repair at not cost to you. Each unit will be repaired and tested. Devices which pass all testing will be returned to the field. For further questions please call 888-521-4277 ext. 4280

Device

Device Recall Allen CFlex Head Positioner
  • Model / Serial
    A128573, A157480, A164957, A165624, A179587, A200505, A200508, A203121, A203123, A203124, A203126, A205717, A205730, A205731, A207969, A207970, A207971, A207973, A208274, A208275, A208277, A208278, A208932, A208933, A208934, A209578, A210915, A210916, A210917, A210919, A210920, A214252, A214253, A214254, A214255, A214256, A214582, A214583, A214584, A215498, A215489, A215499, A215500, A216459, A216460, A216461, A217594, A217595, A217596, A217597, A218945, A219496, A219623, A219624, A220031, A220032, A220033, A220664, A220665, A222121, A222122, A222123, A222394, A223961, A223962, A223963, A223964, A224084, A224085, A224144, A224145, A225106, A225107, A225553, A225554, A22555, A225972, A225973, A226214, A226215, A226216, A226217, A226218, A226910
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide ) and the countries of Africa, Australia, Bulgaria, China, Germany, India, Istanbul, France, Greece, New Zealand, Saudi Arabia,Singapore, Spain, Taiwan and Japan.
  • Product Description
    Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery || Catalog Numbers: A-70700 and A-70701-2
  • 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