Events

Recall of Device Recall Philips Heatlhcare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips 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
    70432
  • Event Risk Class
    Class 2
  • Event Number
    Z-1251-2015
  • Event Initiated Date
    2015-01-23
  • Event Date Posted
    2015-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133671
  • 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, stationary - Product Code KPR
  • Reason
    Improper installation of tube arm, and wall stand may cause it to fall down, improper installation of table may cause it to float.
  • Action
    Philips Healthcare issued notice to foreign Distributors on 1/23/15 to issue and advise customers to stop using the device until a Philips Engineer checks the device. After the engineer verifies that the tube arm, Wall stand and table were properly assembled, the device may be used again. Philips will subsequently install a new Tube Arm and Wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future. Philips will subsequently provide the method to adjust the T-nuts of table to make sure it was properly assembled. A Philips Service Engineer will contact affected customers to install the solution.

Device

Device Recall Philips Heatlhcare
  • Model / Serial
    Serial Numbers: SN120001 SN120002 SN120003 SN130001 SN130002 SN130004 SN130005 SN130015 SN130019 SN130021 SN130003 SN130006 SN130007 SN130009 SN130010 SN130011 SN130012 SN130013 SN130014 SN130016 SN130017 SN130018 SN130020 SN130022 SN130023 SN140001 SN130001 SN130002 SN140001 SN140004 SN140005 SN140008 SN140009 SN140010 SN140012 SN140013 SN140019 SN140020 SN140021 SN140022 SN140024 SN140027 SN140033 SN140034 SN140036 SN140053 SN140062 SN130003 SN140002 SN140003 SN140006 SN140007 SN140016 SN140017 SN140018 SN140031 SN140035 SN140037 SN140039 SN140040 SN140041 SN140044 SN140045 SN140046 SN140048 SN140050 SN140051 SN140052 SN140056 SN140058 SN140060
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, and Uzbekistan.
  • Product Description
    Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic || Models: 712210, 712211
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA