Events

Recall of Integris Allura Radiograph / Fluoroscopy x ray system

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
    69197
  • Event Risk Class
    Class 2
  • Event Number
    Z-0022-2015
  • Event Initiated Date
    2014-08-08
  • Event Date Posted
    2014-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129837
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    Philips had discovered through a field service testing where a device failed to comply with a federal standard.
  • Action
    Philips Healthcare discovered through field service testing, that the device was in violation. Firm service rep. visited site on 7/01/14 and corrected unit. The field service engineer immediately reprogrammed the generator for the X-ray tube installed in the system and re-adapted the x-ray tube to bring the system back into compliance. At this time the Failure to comply has been corrected and the customer has been notified. This correction is to be free of charge to the customer. For further questions please call (978) 687-1501.

Device

Integris Allura Radiograph / Fluoroscopy x ray system
  • Model / Serial
    Model Number: Integris Allura 15-12 Serial Number: 16741023
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to FL
  • Product Description
    Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
  • 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