Events

Recall of Device Recall MobileDiagnost wDR

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
    65839
  • Event Risk Class
    Class 2
  • Event Number
    Z-1964-2013
  • Event Initiated Date
    2013-06-11
  • Event Date Posted
    2013-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120442
  • 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
    The instructions for use (ifu) for the mobilediagnost wdr fails to comply with a federal standard. the ifu does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
  • Action
    Phillips Healthcare sent an Important Notification letter dated July 10, 2013 to all affected customer. The notification informed customers that Philips will implement an update to the Instruction for Use (IFU). Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Philips representative or local Philips Healthcare office.

Device

Device Recall MobileDiagnost wDR
  • Model / Serial
    System Code - 712001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico
  • Product Description
    Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System || Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions. Not intended for mammography.
  • 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