FDA-Device2026-10-27Class IIPROCESSING DEFECT

Philips Azurion 7 B12 imaging systems recalled over unapproved SSDs

OTHERNationwide distributionMedical devices

What this means

Some Philips Azurion 7 B12 systems (model numbers 722067 and 722225) may have solid-state drives installed that are not specified in the device file. These drives may become less reliable over time, which could cause loss of imaging, a blank or black display, or trouble saving or viewing images. No injuries have been reported.

Check whether your facility uses Azurion 7 B12 systems with model number 722067 or 722225.
Compare your system's serial number with the list in the official recall notice.
Contact Philips or your biomedical engineering team for guidance, since no remedy has been specified yet.

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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 (18 years to 120 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

209 units

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Philips Azurion 7 B12. Model Numbers: 722067, 722225.

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. (this page)
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-0296-2027

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