Events

Recall of Device Recall Philips DuraDiagnost (R1.0 product 712210, R2.0 product 712211, and R3.0 product 712211)

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

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
    77410
  • Event Risk Class
    Class 2
  • Event Number
    Z-2322-2017
  • Event Initiated Date
    2017-05-31
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155963
  • 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
    Tube arm assembly could fall down due to cracked welding joints.
  • Action
    Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated May 23, 2017, advising users of the problem and asking facilities to stop using the device until a Philips Engineer can go on-site to perform the FC071200173; contact your local Philips representative if you have any concern or support required on this issue. If you need any further information or support concerning this issue, contact your local Philips representative. For further questions, please call (978) 659-3000.

Device

Device Recall Philips DuraDiagnost (R1.0 product 712210, R2.0 product 712211, and R3.0 product 7...
  • Model / Serial
    SN120001-SN120003, SN130001-SN130023, SN140001-SN140022, SN140024, SN140027, SN140030-SN140031, SN140033-SN140046, SN140048, SN140050-SN140068, SN150001-SN150004, SN150006, SN150008-SN150011, SN160001, SN160002
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : Ca and Oh., and to the countries of: Australia, Libya, China, Mayotte, Mexico, France, United Kingdom, Germany, Ecuador, Australia, Spain, Switzerland, Macedonia, Uzbekistan, Kuwait, Malaysia, Netherlands, Argentina, Chile, Colombia, Egypt, United Arab Emirates, Saudi Arabia, Hungary, Peru, Poland, Indonesia, Burkina Faso, Kazakhstan, Turkey and Slovenia.
  • Product Description
    Philips DuraDiagnost X-ray systems: || DuraDiagnost (R1.0, Product Number 712210) || DuraDiagnost (R2.0, Product Number 712211) || DuraDiagnost (R3.0, Product Number 712211)
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA