Device recall

Philips Azurion 3 M12. Model Numbers: 722063, 722221.

FDA recall source

Recall number

Z-0292-2027

Event id

99939

Status

Ongoing

FDA classification

Class II

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Report date

Nov 4, 2026

Posted

Oct 27, 2026

Initiated

Oct 6, 2026

Center classification date

Oct 27, 2026

Product code

OWB

Device type

Interventional Fluoroscopic X-Ray System

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.

Root cause

Equipment maintenance

Quantity

95 units

Code info

1. Model Number: 722063. UDI Numbers: (01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)77, (01)00884838085275(21)145, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)117, (01)00884838085275(21)99, (01)00884838085275(21)104, (01)00884838085275(21)3, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)14, (01)00884838085275(21)16, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)151, (01)00884838085275(21)93, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)92, (01)00884838085275(21)59, (01)00884838085275(21)139, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)27, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)86, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55, (01)00884838085275(21)113. Serial Numbers: 56, 96, 98, 77, 145, 47, 80, 146, 117, 99, 104, 3, 144, 62, 61, 22, 153, 40, 70, 30, 25, 121, 18, 14, 16, 17, 53, 101, 143, 41, 151, 93, 150, 105, 129, 21, 78, 23, 92, 59, 139, 154, 75, 27, 24, 94, 100, 26, 106, 37, 36, 135, 123, 89, 86, 79, 133, 81, 140, 52, 48, 148, 55, 113. 2. Model Number: 722221. UDI Numbers: (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838099203(21)115, (01)00884838099203(21)177, (01)00884838099203(21)124, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)159, (01)00884838099203(21)60, (01)00884838099203(21)33, (01)00884838099203(21)55, (01)00884838099203(21)44, (01)00884838099203(21)142, (01)00884838099203(21)144, (01)00884838099203(21)126, (01)00884838099203(21)147, (01)00884838099203(21)26, (01)00884838099203(21)23, (01)00884838099203(21)133, (01)00884838099203(21)167, (01)00884838099203(21)15, (01)00884838099203(21)74, (01)00884838099203(21)202, (01)00884838099203(21)22, (01)00884838099203(21)58, (01)00884838099203(21)165, (01)00884838099203(21)78, (01)00884838099203(21)174, (01)00884838099203(21)176, (01)00884838099203(21)207. Serial Numbers: 6, 93, 115, 177, 124, 106, 151, 71, 159, 60, 33, 55, 44, 142, 144, 126, 147, 26, 23, 133, 167, 15, 74, 202, 22, 58, 165, 78, 174, 176, 207.

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.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K172822K181830K200917

Location

Best, Netherlands