FDA recall, , Moderate risk
Philips Allura Xper FD10, FD20 and Biplane Systems
Philips Allura Xper systems may have a missing drip tray, allowing coolant to contact electrical components and cause short-circuits.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V. is recalling certain Allura Xper systems because 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. The recall began December 15, 2025, and was added to FDA's Enforcement Report on January 13, 2026.
The recall affects multiple models, including Allura Xper FD20/20, FD10/10, FD20 Biplane, FD20, FD10F, FD10, FD10C, FD20 OR Table, and FD20/10, distributed worldwide, including across the U.S. and in countries such as Argentina, Australia, Belgium, Brazil, and others. The company has identified the issue in a limited number of impacted systems.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
Allura Xper FD20 Biplane
- UDI-DI
- 00884838059061
- Model code
- 722013
- UDI-DI
- 722008530
- Model code
- 722008
722001
722002
722003
722005
722006
722008
722010
722011
722012
Show the other 14 products
722013
722023
722026
722027
722028
722029
722038
Allura Xper FD20/20
- UDI-DI
- 00884838054226
- Model code
- 722038
Allura Xper FD10/10
- UDI-DI
- 00884838059047
- Model code
- 722011
- UDI-DI
- 00884838054196
- Model code
- 722027
Allura Xper FD20
- UDI-DI
- 00884838054202
- Model code
- 722028
- UDI-DI
- 00884838059054
- Model code
- 722012
Allura Xper FD10F
- Model code
- 722002
- Codes
- Not listed here. See the FDA notice.
Allura Xper FD20 OR Table
- UDI-DI
- 00884838059085
- Model code
- 722023
Allura Xper FD10
- UDI-DI
- 00884838054189
- Model code
- 722026
- UDI-DI
- 00884838059030
- Model code
- 722010
Allura Xper FD20/10
- UDI-DI
- 00884838054219
- Model code
- 722029
Recall details
- Company began the recall
- Sold in
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.
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, Netherlands
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98109
- Recall numbers
- Z-1062-2026 to Z-1077-2026
All recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
