Events

Recall of Philips DigitalDiagnost Systems

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
    62884
  • Event Risk Class
    Class 2
  • Event Number
    Z-2384-2012
  • Event Initiated Date
    2012-08-14
  • Event Date Posted
    2012-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111935
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Creepage distance between the two primary phases in the geo transformer is 4.5 mm.Does not meet (iec) international standard of 5.5 mm.
  • Action
    Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Philips DigitalDiagnost Systems
  • Model / Serial
    Lot or Serial Numbers With affected M-cabinet CXA;  Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including OH and WA and the country of Canada
  • Product Description
    Philips DigitalDiagnost Systems with M Cabinet || Model: 712025 || Stationary radiographic system, digital-Universal RAD Applications
  • 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