FDA-Device2026-10-27Class IIPROCESSING DEFECT

Philips Azurion S system recalled over unapproved solid-state drives

OTHERNationwide distributionMedical devices

What this means

Philips is recalling Azurion S systems (model 722285) because solid-state drives not specified in the device file may have been installed in the PCs. These drives may perform differently and could become less reliable over time, leading to loss of imaging, a blank or black display, or trouble storing and viewing images. One unit is affected, and no injuries have been reported.

Contact Philips or your authorized service provider to check whether the system's PC has an unspecified SSD.
Confirm whether your unit's serial number matches the recall notice.

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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 unit

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Philips Azurion S. Model Number: 722285.

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.
Z-0299-2027 · 1,896 units
Philips Azurion S. Model Number: 722285. (this page)
Z-0300-2027 · 1 unit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0300-2027

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