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Moderate riskFDA DeviceClass II

Philips Azurion 3 M15 imaging system recalled for unexpected table movement

Philips medical imaging tables (Azurion 3 M15 systems) may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is engaged. This affects specific model numbers with software versions R1.X, R2.X, and R3.X.

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

What to do

  1. If your facility uses a Philips Azurion 3 M15 system, contact Philips immediately for instructions
  2. Do not use the Reset Geometry function until you receive guidance from Philips
  3. Verify your system's model number and software version against the recall notice
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(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
802 units (45 US, 757 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 4-6, N/A, Best, N/A, Netherlands
Classification
Class II
Recall number
Z-1345-2026

In the FDA's words

Description
Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(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) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); UDI-DIs: (1) 884838085282, (2) 884838099210, (3) 884838116733, (4)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: 802 units (45 US, 757 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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