Philips Azurion 5 M12 Recall
Philips Azurion 5 M12. Model Number: 722227.
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Philips Azurion 5 M12 recalled?
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 should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Philips Azurion 5 M12. Model Number: 722227.
Which lot codes, UPCs or models are 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.
- Agency record number
- Z-0294-2027
- Product
- Philips Azurion 5 M12. Model Number: 722227.
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 60 units
- Distribution
- 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.
- Recall started
- October 6, 2026
- Report date
- November 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)