FDA-Device2026-01-21Class IIPROCESSING DEFECT

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

ELECTRICAL SHOCKOTHERNationwide distributionMedical devices

What this means

Philips identified that some Allura Xper FD10 X-ray systems may be missing a drip tray beneath the cooling unit due to incomplete field repairs. If the tray is not in place, coolant can leak onto electrical components and cause short-circuits, potentially shutting down the system.

  • Check if your system's serial number matches the recall list
  • Verify the drip tray is installed beneath the cooling unit
  • Contact Philips Medical Systems if you have questions or need assistance
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
93 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Allura Xper FD10; Model Number: 722003;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2026

More Philips recalls

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