FDA-Device2026-06-03Class IIPROCESSING DEFECT

Philips Allura medical imaging systems recalled for hard drive failure risk

OTHERNationwide distribution

Philips Allura imaging systems recalled for drive failure

Hard drives in Philips Allura X-ray imaging systems may degrade after six years of use, potentially causing loss of imaging capability, motorized movement, or data. Some systems may temporarily restore function after a restart.

If your facility operates an affected Allura system, contact Philips for guidance on drive replacement or monitoring.
Track the age of your system's hard drive and plan for replacement before six years of service.
Document any imaging loss or system malfunction and report it to Philips and your equipment maintenance team.

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.

Manufactured in

Veenpluis 6, Best, Netherlands

Products

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2259-2026

More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls

FDA-Device2026-06-03
Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
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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