Events

Recall of AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems.

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
    33873
  • Event Risk Class
    Class 2
  • Event Number
    Z-0208-06
  • Event Initiated Date
    2005-10-12
  • Event Date Posted
    2005-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42975
  • 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
    System, X-Ray, Angiographic - Product Code IZI
  • Reason
    Potential for high voltage exposure involving the injector interface connector of patient support tables.
  • Action
    On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.

Device

AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cab...
  • Model / Serial
    See site numbers listed above
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed nationwide to hospitals/medical centers.
  • Product Description
    AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems.
  • 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