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Moderate riskFDA DeviceClass II

Philips Azurion 7 B12 imaging system recalled for unexpected table movement

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.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. Stop using the Reset Geometry function on affected Azurion 7 B12 systems immediately
  2. Contact Philips Medical Systems Nederland B.V. for instructions on a software update or repair
  3. Verify your system model number (722067, 722225, or 722235) and software version (R1.X, R2.X, or R3.X) against the recall list
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 8 products — see all of them.

Details

Units affected
655 units (106 US, 549 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Classification
Class II
Recall number
Z-1346-2026

In the FDA's words

Description
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. System Model Numbers:(1)722067, (2)722225, (3)722235; UDI-DIs:(1)884838085350, (2)884838099265, (3)884838116788; Serial Numbers: All; Distribution: 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 quantity: 655 units (106 US, 549 OUS)
Hazard
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

8 products in this recall

Philips Azurion systems recalled for unexpected table movement

Philips is recalling eight Azurion 3, 5, and 7 X-ray system models. Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed, even when a table lock is active. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from Philips

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