PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion 5 M20.

Recalling company

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Philips Azurion 5 M20. Model Numbers: 722228, 722281.

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 6, 2026

Reported

Nov 4, 2026

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.

Status

Ongoing

Quantity

465 units

Lot / codes

1. Model Number: 722228. UDI Numbers: (01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)180, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)533, (01)00884838099234(21)47, (01)00884838099234(21)522, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)431, (01)00884838099234(21)113, (01)00884838099234(21)529, (01)00884838099234(21)659, (01)00884838099234(21)145, (01)00884838099234(21)567, (01)00884838099234(21)539, (01)00884838099234(21)645, (01)00884838099234(21)308, (01)00884838099234(21)333, (01)00884838099234(21)335, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)44, (01)00884838099234(21)569, (01)00884838099234(21)418, (01)00884838099234(21)280, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)471, (01)00884838099234(21)428, (01)00884838099234(21)465, (01)00884838099234(21)102, (01)00884838099234(21)176, (01)00884838099234(21)103, (01)00884838099234(21)178, (01)00884838099234(21)109, (01)00884838099234(21)16, (01)00884838099234(21)234, (01)00884838099234(21)566, (01)00884838099234(21)571, (01)00884838099234(21)463, (01)00884838099234(21)647, (01)00884838099234(21)317, (01)00884838099234(21)562, (01)00884838099234(21)552, (01)00884838099234(21)680, (01)00884838099234(21)724, (01)00884838099234(21)561, (01)00884838099234(21)517, (01)008848380

Company location

Best

Recall type

Voluntary: Firm initiated

Recall number

Z-0295-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0295-2027 in the FDA Enforcement Report. Also see FDA recall press releases.