Events

Recall of Device Recall Allura Xper FD 10/10

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

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
    36196
  • Event Risk Class
    Class 2
  • Event Number
    Z-0161-2007
  • Event Initiated Date
    2006-08-24
  • Event Date Posted
    2006-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48181
  • 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
    x-ray, angiographic system - Product Code IZI
  • Reason
    Potential for x-ray system to freeze during an examination, and inability of table to be re-positioned.
  • Action
    A letter dated September 1, 2006 was sent to customers on September 5, 2006. The letter advised customers of the problem and advised a service representative will visit the consignee to install a new software upgrade.

Device

Device Recall Allura Xper FD 10/10
  • Model / Serial
    Site numbers for both FD 10/10 and FD 10:  532800, 544506, 543702, 543289, 543209, 543200, 543194, 542714, 542557, 542413, 542117, 542113, 541822, 541592, 541577, 541409, 541029, 541026, 540841, 540488, 540386, 540311, 540301, 540269, 540237, 540235, 540234, 540184, 540070, 540016, 539641, 539628, 539595, 539480, 539455, 539326, 539107, 538903, 538744, 538516, 538514, 538486, 538485, 538476, 538409, 538368, 538157, 538084, 538028, 537855, 537804, 537745, 537698, 537631, 537630, 536966, 536721, 536379, 536138, 536042, 536037, 536035, 536034, 536031, 536028, 535769, 535667, 535416, 535415, 534941, 534731, 534678, 534638, 534634, 533762, 533397, 533289, 533283, 533282, 533278, 532799, 532611, 531942, 530667, 530666, 104497, 103283
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Allura Xper FD 10/10 x-ray, angiographic system
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA