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Moderate riskFDA DeviceClass II

Philips Azurion 5 M20 imaging system recalled for unexpected table movement

Philips Azurion 5 M20 X-ray imaging systems may move their patient table unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. This could occur under certain conditions and pose a risk during medical procedures.

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

What to do

  1. If you operate or manage an Azurion 5 M20 system (model 722228, 722232, or 722281), stop using it immediately
  2. Contact Philips Medical Systems for instructions on a software update or replacement
  3. Do not press the Reset Geometry button until the issue is resolved
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); 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
922 units (101 US, 821 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Classification
Class II
Recall number
Z-1351-2026

In the FDA's words

Description
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); 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)722228, (2)722232, (3)722281(OUS only); UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A; 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: 922 units (101 US, 821 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.

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