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 identified that some Allura Xper FD20 Biplane X-ray systems may be missing a drip tray under the cooling unit, either from incomplete past repairs or undocumented installation. Without this tray, coolant liquid could leak onto electrical components and cause short-circuits that shut down the system.

  • Check your system serial number against the list of 23 affected units (serial numbers 601, 230, 370, 27, 320, 193, 60, 373, 560, 400, 549, 506, 381, 382, 132, 169, 233, 236, 243, 526, 447, 163, 403)
  • If your system is affected, contact Philips Medical Systems to verify the drip tray is installed and properly documented
  • Do not operate the system if you suspect the drip tray is missing
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
23 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Allura Xper FD20 Biplane; Model Number: 722013;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1071-2026

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