FDA-Device2026-01-21Class IIPROCESSING DEFECT

Philips Allura Xper FD10C X-ray system recalled for missing coolant drip tray

ELECTRICAL SHOCKOTHERNationwide distribution

Contact Philips about your Allura Xper FD10C system

Philips has identified that some Allura Xper FD10C X-ray systems may be missing a drip tray that sits beneath the cooling unit, or the installation was not properly documented during previous maintenance. Without this tray, coolant liquid could leak onto electrical components and cause short circuits, potentially shutting down the system.

  • Check if your facility operates an Allura Xper FD10C (Model 722001)
  • Verify the drip tray is installed beneath the cooling unit
  • Contact Philips Medical Systems if you have questions or need verification
Hazard

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.
Affected count
38 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Product Name: Allura Xper FD10C; Model number: 722001;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1062-2026

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