Recall of Device Recall Philips Healthcare Allura XPER FD20

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Angiographic X-Ray System - Product Code IZI
  • Reason
    Adjustment of the micro-switches in the footswitch used on the philips cardiovascular x-ray systems was not implemented. if it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release itself. the patient may be exposed to x-ray longer than intended.
  • Action
    On 11/5/10, Philips began sending the Electronic Product Radiation Warning notification letter, dated November 4, 2010, to their consignees. The consignees were informed that the middle pedal of the foot switch of the Allura FD10, FD20, CV20 systems, and the Allura Field Extension series does not not always become inactive (sticks) when pedal is released. The function of the middle pedal on the foot switch is freely programmable by the customer. If it is programmed for exposure and if the pedal does not release by itself, the patient will be exposed to X-ray longer than intended. The consignees were advised to check if their footswitch is possibly affected. Footswitch identification 452270000141 is noted. If the pedal does not release by itself press the red emergency stop button on the system. Consignees can call Philips Healthcare Call Center at 800-722-9377, #5 and Reference FCO 72200189.


  • Model / Serial
    Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
  • Product Description
    Allura XPER FD 20 and and Allura CV20; || Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. || Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
  • Manufacturer


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