FDA-Device2026-01-21Class IIPROCESSING DEFECT

Philips Allura Xper FD10/10 X-ray system recalled for missing coolant drip tray

ELECTRICAL SHOCKFIRENationwide distribution

Check your Philips Allura Xper FD10/10 system

Philips identified that some Allura Xper FD10/10 X-ray systems may be missing a drip tray that protects electrical components from coolant liquid. If the tray was not installed during a previous service, coolant could contact electrical parts and cause a short circuit, potentially shutting down the system.

  • Check if your system's serial number is on the affected list (268, 205, 213, 89, 293, 294, 116, 272, 113, 152, 112, 139, 141, 111, 81, 66, 46, 153, 115, 114, 274)
  • Contact Philips Medical Systems or your device representative to verify the drip tray is installed
  • Request documentation confirming installation if you've had recent service on this system
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
21 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Allura Xper FD10/10; Model Number: 722011;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2026

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