FDA Medical devices recall · January 21, 2026

Philips Azurion Systems R3.0. Includes the following label descriptions… recall

Read the official FDA notice ↗

Product

Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5. Azurion 7 B12. Model Number: 722235. 6. Azurion 7 B20. Model Number: 722236. 7. Azurion 7 M12. Model Number: 722233. 8. Azurion 7 M20. Model Number: 722234.

Why was it recalled?

Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Software Version: R3.0. 1. Model Number: 722229. UDI Numbers: (01)00884838116726(21)22, (01)00884838116726(21)15, (01)00884838116726(21)16, (01)00884838116726(21)6, (01)00884838116726(21)8, (01)00884838116726(21)4, (01)00884838116726(21)24, (01)00884838116726(21)26, (01)00884838116726(21)20, (01)00884838116726(21)25, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13, (01)00884838116726(21)7, (01)00884838116726(21)10, (01)00884838116726(21)2, (01)00884838116726(21)3, (01)00884838116726(21)29. 2. Model Number: 722230. UDI Numbers: (01)00884838116733(21)2, (01)00884838116733(21)40, (01)00884838116733(21)9, (01)00884838116733(21)1, (01)00884838116733(21)38, (01)00884838116733(21)10, (01)00884838116733(21)45, (01)00884838116733(21)7, (01)00884838116733(21)27, (01)00884838116733(21)28, (01)00884838116733(21)39, (01)00884838116733(21)4, (01)00884838116733(21)5, (01)00884838116733(21)23, (01)00884838116733(21)41, (01)00884838116733(21)20, (01)00884838116733(21)19, (01)00884838116733(21)13, (01)00884838116733(21)15, (01)00884838116733(21)12, (01)00884838116733(21)22. 3. Model Number: 722231. UDI Numbers: (01)00884838116740(21)13, (01)00884838116740(21)29, (01)00884838116740(21)50, (01)00884838116740(21)21, (01)00884838116740(21)19, (01)00884838116740(21)12, (01)00884838116740(21)25, (01)00884838116740(21)4, (01)00884838116740(21)1, (01)00884838116740(21)5, (01)00884838116740(21)2, (01)00884838116740(21)73, (01)00884838116740(21)72, (01)00884838116740(21)75,

Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Chile, Colombia, Cote de'Ivore, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Kazakhstan, Kosovo, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Palestine, Philippines, Poland, Portugal, R¿union, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkiye, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1079-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.