FDA-Device2026-01-21Class IIPROCESSING DEFECT

Philips Allura Xper FD20 Biplane X-ray system recalled for missing coolant drip tray

ELECTRICAL SHOCKFIRENationwide distribution

Check your Philips Allura Xper FD20 system

Philips has identified that 18 Allura Xper FD20 Biplane X-ray systems worldwide may be missing a drip tray beneath the cooling unit due to incomplete field repairs or missing documentation. Without this tray, coolant liquid could contact electrical components and cause short circuits that shut down the system.

  • Check your device serial number against the list provided by Philips
  • Verify the drip tray is installed beneath the cooling unit
  • Contact Philips Medical Systems for inspection or repair if your system is affected
  • Do not operate the system if the drip tray is missing or you cannot confirm its installation
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
18 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Allura Xper FD20 Biplane; Model Number: 722008;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1067-2026

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