Events

Recall of Device Recall Philips Imaging

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Healthcare 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
    61779
  • Event Risk Class
    Class 2
  • Event Number
    Z-1689-2012
  • Event Initiated Date
    2012-05-02
  • Event Date Posted
    2012-05-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109064
  • 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, mobile - Product Code IZL
  • Reason
    Unexpected low-level x-ray pulse.
  • Action
    Philips sent a Urgent Field Safety Notice dated April 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of the communication. Please retain a copy with the equipment instruction for Use. A Philips Service Engineer will contact account as soon as the Field Action Kit is ready to be implemented. Communicate with Philips with regard to this program, please reference Field Change Order 70400049. Further questions please contact your local Philips representative at 1-800-722-9377. On 2/6/15, Philips reported that the recall was extended to an additional 88 units that were unit stock that did receive the correction. Philips issued recall notifcation letter (FCO70400049) on 1/20/2015 to users. Control boards will replaced by a Philips Service Engineer.

Device

Device Recall Philips Imaging
  • Model / Serial
    Serial numbers: PC1-0504 through PC1 -0588. Extended recall 1/20/2015 (88 units): 484947/SNPC1-0579 375495 423986/SNPC1-0406 423986/SNPC1-0406 423990/SNPC1-0410 465801/SNPC1-0499 465801/SNPC1-0499 365636 365637 365637 365635 392508/SNPC1-0281 479454/SNPC1-0559 352064 352064 323714 455129/SNPC1-0474 423985/SNPC1-0396 423985/SNPC1-0396 411312/SNPC1-0343 411312/SNPC1-0343 328312 328312 345399 345399 345402 345402 345402 380754 380754 424721/SN424721PC1 380965 312998 PC1-0265 314440 314440 386105/SNPC1-0272 425484/SNPC1-0401 425484/SNPC1-0401
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-- USA ( nationwide ) including the states of IA, LA, LA, ND, NY, OH and TX and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Germany, Hong Kong, Indonesia, Italy, Malaysia, Mexico, Netherlands, Philippines, Qatar, Russia, Saudi Arabia, Singapore, South Africa,Thailand and Ukraine.
  • Product Description
    Philips Practix Convenio Mobile X-ray System || Model: 70455 || The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Manufacturer Address
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA