FDA-Device2026-10-27Class IIPROCESSING DEFECT

Philips Azurion 7 M20 imaging systems recalled over unapproved SSDs

OTHERNationwide distributionMedical devices

What this means

Philips recalled 1,896 Azurion 7 M20 systems (model numbers 722079, 722224, and 722282) because some solid-state drives not listed in the device file may have been installed in their PCs. These drives may perform differently and become less reliable over time, which could lead to lost imaging or motorized movement, a blank or black display, or problems storing or accessing images. No injuries have been reported.

Contact Philips or your facility's biomedical engineering team to confirm whether your system is included.
Follow any instructions from Philips, since this notice does not specify a remedy.
Report any display failures, image storage problems, or unexpected motion to Philips and your facility.

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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

1,896 units

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

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.
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. (this page)
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-0299-2027

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