FDA recall, , Moderate risk
Philips Allura Xper and Azurion Angiography Systems
Philips Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.
Summary by Recall Canary from the FDA notice
What happened
Philips Medical Systems Nederland B.V. is recalling certain Allura Xper and Azurion imaging systems because X-ray imaging may not initiate or may occur intermittently when using the wired foot switch.
The recall covers multiple models, including Allura Xper FD20 Biplane, Azurion 7 B20, Allura Xper FD20/15 OR Table, Azurion 5 M12, Azurion 3 M12, Allura Xper FD10F, Allura Xper FD20 Biplane OR Table, and Azurion 3 M15, among others. The company began the recall on March 3, 2026, and the FDA added it to its Enforcement Report on March 27, 2026.
Distribution was nationwide in the U.S. and internationally.
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?
22 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
- UDI-DI
- 00884838059061
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
- UDI-DI
- 00884838085367
- 00884838099272
- 00884838116788
Allura Xper FD20/15 OR Table; System Code: 722059;
- UDI-DI
- 00884838059122
Azurion 5 M12; System Code: (1)722227, (2)722231;
- UDI-DI
- 00884838099227
- 00884838099258
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
- UDI-DI
- 00884838085275
ALLURA Xper FD10F; System Code: 722002;
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
- UDI-DI
- 00884838059108
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
- UDI-DI
- 00884838085282
- 00884838099210
- 00884838116733
- 00884838103276
Allura Xper FD20/10; System Code: 722029;
- UDI-DI
- 00884838059078
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
- UDI-DI
- 00884838059085
- 00884838054240
Show all 22 products
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
- UDI-DI
- 00884838085251
- 00884838099241
- 00884838116764
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
- UDI-DI
- 00884838099234
- 00884838116757
- 00884838110564
Allura Xper FD20/20 OR Table; System Code: 722039;
- UDI-DI
- 00884838054271
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
- UDI-DI
- 00884838059078
- 00884838054233
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
- UDI-DI
- 00884838059047
- 00884838054196
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
- UDI-DI
- 100079164
- 00884838059054
- 00884838054202
- 23040202
Allura Xper FD10C; System Code: 722001;
- UDI-DI
- 18661014
Allura Xper FD20/20; System Code: 722038;
- UDI-DI
- 00884838054226
Allura Xper FD20/15; System Code: 722058;
- UDI-DI
- 00884838059115
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
- UDI-DI
- 00884838085350
- 00884838099265
- 00884838116788
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
- UDI-DI
- 00884838085268
- 00884838099258
- 00884838116771
- 00884838110571
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
- UDI-DI
- 00884838059030
- 00884838054189
Recall details
- Company began the recall
- Sold in
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, 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
- 98434
- Recall numbers
- Z-1659-2026 to Z-1680-2026
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
Summary updated
