FDA-Device2026-02-18Class IIPROCESSING DEFECT
Philips Azurion 7 B12 imaging system recalled for unexpected table movement
What this means
The examination table on certain Philips Azurion 7 B12 X-ray imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This could pose a safety risk to patients or staff during procedures. No injuries have been reported.
- Stop using the Reset Geometry function on affected Azurion 7 B12 systems immediately
- Contact Philips Medical Systems Nederland B.V. for instructions on a software update or repair
- Verify your system model number (722067, 722225, or 722235) and software version (R1.X, R2.X, or R3.X) against the recall list
The agency's original wording
Hazard
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
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-Herz., Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.
Affected count
655 units (106 US, 549 OUS)
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Products
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1346-2026More Philips recalls
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