Philips Azurion 5 M12. Model Number: 722227. recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)

Medical deviceClass IIOngoing

Summary: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is recalling Philips Azurion 5 M12. Model Number: 722227.. Reason: Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

What is being recalled

Philips Azurion 5 M12. Model Number: 722227.

Why

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, 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, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

How to tell if yours is affected

Model Number: 722227. UDI Numbers: (01)00884838099227(21)135, (01)00884838099227(21)88, (01)00884838099227(21)271, (01)00884838099227(21)127, (01)00884838099227(21)128, (01)00884838099227(21)179, (01)00884838099227(21)270, (01)00884838099227(21)246, (01)00884838099227(21)338, (01)00884838099227(21)108, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)104, (01)00884838099227(21)109, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)215, (01)00884838099227(21)213, (01)00884838099227(21)216, (01)00884838099227(21)226, (01)00884838099227(21)83, (01)00884838099227(21)251, (01)00884838099227(21)268, (01)00884838099227(21)309, (01)00884838099227(21)316, (01)00884838099227(21)290, (01)00884838099227(21)310, (01)00884838099227(21)345, (01)00884838099227(21)116, (01)00884838099227(21)153, (01)00884838099227(21)262, (01)00884838099227(21)204, (01)00884838099227(21)113, (01)00884838099227(21)110, (01)00884838099227(21)256, (01)00884838099227(21)308, (01)00884838099227(21)90, (01)00884838099227(21)200, (01)00884838099227(21)362, (01)00884838099227(21)242, (01)00884838099227(21)136, (01)00884838099227(21)95, (01)00884838099227(21)2, (01)00884838099227(21)221, (01)00884838099227(21)165, (01)00884838099227(21)16, (01)00884838099227(21)12, (01)00884838099227(21)257, (01)00884838099227(21)284, (01)00884838099227(21)248, (01)00884838099227(21)26, (01)00884838099227(21)292, (01)00884838099227(21)58, (01)00884838099227(21)130, (01)00884838099227(21)125, (01)00884838099227(21)184, (01)00884838099227(21)57, (01)00884838099227(21)131. Serial Numbers: 135, 88, 271, 127, 128, 179, 270, 246, 338, 108, 305, 356, 346, 313, 104, 109, 337, 306, 215, 213, 216, 226, 83, 251, 268, 309, 316, 290, 310, 345, 116, 153, 262, 204, 113, 110, 256, 308, 90, 200, 362, 242, 136, 95, 2, 221, 165, 16, 12, 257, 284, 248, 26, 292, 58, 130, 125, 184, 57, 131.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · all medical device recalls · recalls from October 2026

Official FDA record