FDA-Device2026-10-27Class IIPROCESSING DEFECT

Philips Azurion 5 M12 imaging systems recalled over unapproved SSDs

OTHERNationwide distributionMedical devices

What this means

Some Philips Azurion 5 M12 systems (model 722227) may contain solid-state drives that are not listed in the device's approved specifications. These drives may perform differently and could become less reliable over time. Reported problems could include lost imaging function, a blank or black screen, or trouble storing or accessing images.

Check whether your Azurion 5 M12 (model 722227) is on the affected serial number list.
Contact Philips Medical Systems for guidance and the corrective remedy before continuing to rely on an affected unit.
Keep records of any affected systems in 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

Adults

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

60 units

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Philips Azurion 5 M12. Model Number: 722227.

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. (this page)
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.
Z-0300-2027 · 1 unit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2027

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