FDA-Device2026-10-27Class IIPROCESSING DEFECT

Philips Azurion 5 M20 systems recalled over unapproved SSD drives

OTHERNationwide distributionMedical devices

What this means

Philips recalled certain Azurion 5 M20 systems, models 722228 and 722281, because unspecified solid-state drives may have been installed in the PCs. These drives may perform differently and could become less reliable over time, which may affect imaging, the display, or the ability to store and retrieve images. No injuries have been reported.

Check whether your facility's Azurion 5 M20 is a listed model number and UDI.
Contact Philips for the recall remedy and instructions for the affected systems.
Report any display, imaging, or image storage problems to the manufacturer and your facility's biomedical team.

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The agency's original wording

Hazard

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.

Intended for

All ages (under 100 years)

Illnesses reported

None reported

Sold states

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.

Affected count

465 units

Manufactured in

Veenpluis 6, Best, Netherlands

Products

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

Products in this recall · 9

The agency lists each product in this recall separately. Check every one you might have.

Philips Azurion 3 M12. Model Numbers: 722063, 722221.
Z-0292-2027 · 95 units
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
Z-0293-2027 · 519 units
Philips Azurion 5 M12. Model Number: 722227.
Z-0294-2027 · 60 units
Philips Azurion 5 M20. Model Numbers: 722228, 722281. (this page)
Z-0295-2027 · 465 units
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
Z-0296-2027 · 209 units
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
Z-0297-2027 · 457 units
Philips Azurion 7 M12. Model Numbers: 722078, 722223.
Z-0298-2027 · 602 units
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
Z-0299-2027 · 1,896 units
Philips Azurion S. Model Number: 722285.
Z-0300-2027 · 1 unit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2027

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