Home/Recalls/FDA-Z-1075-2026
FDA DevicesClass II

Allura Xper FD20; Model Number: 722028;

Published: January 21, 2026Recall ID: Z-1075-2026Category: devicesCountry: US

Reason for Recall / 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.

Product Description & Identification

Allura Xper FD20; Model Number: 722028;

Additional Source Details

FieldValue
CityBest
Event id98109
Address 1Veenpluis 4-6
Code infoModel Number: 722028; System Product Name: Allura Xper FD20; UDI-DI: 00884838054202; Serial Numbers: 893, 614;
Postal codeN/A
Report date20260121
Product typeDevices
Product quantity2 units
Reason for recallPhilips 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251215
Initial firm notificationLetter
Center classification date20260113

Overview

  • Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide 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.
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