Events

Recall of Device Recall AD 7 Patient table

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

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
    47487
  • Event Risk Class
    Class 2
  • Event Number
    Z-1642-2008
  • Event Initiated Date
    2008-03-14
  • Event Date Posted
    2008-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69564
  • 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 - Product Code IXI
  • Reason
    Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
  • Action
    On 03/22/2004, firm sent letters via certified mail to notify customers of issue. Letter advises customers of potential risk for patients and users, and states to not use system for critical examinations or treatments if table movements suddenly stops or makes a freeing movement. The letter indicates a representative will contact customer for installation of a Hardware filter, free of charge, to prevent Electromagnetic interference (EMI) from affecting the force sensor. Please contact Philips at 1-800-722-9377 #5, #4, #1.

Device

Device Recall AD 7 Patient table
  • Model / Serial
    Part number 9896 002 04432
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product is distributed to hospitals and medical centers nationwide to the following states: ND, FL, KY, MN, VA, ME, PA, NJ, CT, TX, CA, OH, TN, OR, GA, NY, SC, MO, WA, IL.
  • Product Description
    AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA