FDA-Device2026-01-21Class IIPROCESSING DEFECT

Philips Allura Xper FD10 X-ray system recalled for missing cooling drip tray

ELECTRICAL SHOCKFIRENationwide distributionMedical devices

What this means

Philips identified that in 56 X-ray systems worldwide, a drip tray beneath the cooling unit may not have been installed during previous maintenance, or the installation may not have been properly documented. If missing, coolant liquid could contact electrical components and cause a short circuit, potentially shutting down the system.

  • Verify that your Allura Xper FD10 (Model 722010) has the drip tray installed beneath the cooling unit
  • Check your system's serial number against the list provided by Philips
  • Contact Philips Medical Systems if your system is affected or if you need verification
  • Do not operate the system if you cannot confirm the drip tray is in place
The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
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
56 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Allura Xper FD10; Model Number: 722010;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1068-2026

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