FDA-Device2026-06-03Class IIPROCESSING DEFECT

Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality

OTHERNationwide distribution

Philips Azurion imaging systems recalled for hard drive failure

Hard drives in Philips Azurion imaging systems may degrade after six years of use, potentially causing loss of imaging capability. In some cases, the system may need to be restarted to restore function temporarily. Philips has identified this issue in multiple Azurion models used in medical facilities.

If your facility operates an Azurion system beyond six years old, contact Philips for guidance on hard drive inspection and replacement
Monitor your system for performance issues or imaging disruptions
Keep Philips support contact information readily available for troubleshooting

Hazard

It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.

Sold states

Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

Affected count

3069 units (872 US, 2224 OUS)

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2258-2026

More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls

FDA-Device2026-06-03
Philips Allura medical imaging systems recalled for hard drive failure risk
FDA-Device2026-05-27
Philips Azurion X-ray systems recalled for cooling hose degradation risk
FDA-Device2026-05-27
Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
FDA-Device2026-05-27
Philips Azurion X-ray systems recalled for impaired table movement due to control wear
FDA-Device2026-05-27
Philips Allura X-ray systems recalled for potential cooling unit oil leakage

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