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 14 of their Allura Xper FD10/10 X-ray systems may be missing a drip tray beneath the cooling unit. Without this tray, coolant liquid could contact electrical parts and cause a short-circuit, potentially shutting down the system.

  • Contact Philips Medical Systems to confirm whether your system (Model 722005) has the drip tray installed
  • Do not operate the system if you cannot confirm the drip tray is in place
  • Request Philips to install or verify installation of the cooling unit drip tray
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
14 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Allura Xper FD10/10; Model Number: 722005;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1065-2026

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