Recall Weekly
Moderate riskFDA DeviceClass II

Philips Azurion 5 M12 imaging system recalled for unexpected table movement

The table on certain Philips Azurion 5 M12 imaging systems may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects 326 units distributed worldwide, including 10 in the United States. No injuries have been reported.

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

What to do

  1. Identify whether your system is model 722227 or 722231 with software version R1.X, R2.X, or R3.X
  2. Stop using the Reset Geometry button until you receive instructions from Philips Medical
  3. Contact Philips Medical Systems Nederland B.V. for guidance on a software update or repair
  4. Document your system's serial number for reference when contacting the manufacturer
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; 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
326 units (10 US, 316 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Classification
Class II
Recall number
Z-1350-2026

In the FDA's words

Description
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; 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)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; 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: 326 units (10 US, 316 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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