Events

Recall of Allura

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
    36573
  • Event Risk Class
    Class 2
  • Event Number
    Z-0165-2007
  • Event Initiated Date
    2006-10-12
  • Event Date Posted
    2006-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48924
  • 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 and fluoroscopy - Product Code IZI
  • Reason
    Potential for generator to lock-up. fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
  • Action
    On 10/12/06 the firm issued a letter to their consignees advising of the problem and how to avoid the problem by using specific image formats. If the system should lock up, consignees are to switch the system off and then restart. The firm will be conducting software upgrades to the devices once software is ready (estimated time for FD 10/10 is November 2006 and estimated time for FD 20/10 is January 2007). Later, the firm identified 8 additional units and issued a letter on 12/11/06 to affected customers.

Device

Allura
  • Model / Serial
    127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95, 27, 6, 47, 98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89, 23, 33, 31, 30, 29, 28, 32, 100, 63, 61 Additional units are identified with site numbers: 533397, 531926, 104950, 104953, 103283, 103281, 530653, 104497
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Allura X-per FD 10/10 x-ray, and fluoroscopy
  • 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