PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura system

Recalling company

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

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);

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Apr 30, 2026

Reported

Jun 3, 2026

Distribution

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.

Status

Ongoing

Lot / codes

1. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 445, 1555, 1114, 1529, 472, 1349, 1594, 1311, 1472, 1187, 1700, 1031, 912, 913, 940, 285, 1637, 5, 797, 639, 452, 1585, 535, 1338, 1641, 1916, 614, 605, 492, 1612, 505, 239, 1216, 1169, 1118, 115, 519, 356, 715, 423, 1399, 789, 1509, 1016, 875, 1923, 313, 314, 1919, 1458, 369, 1176, 1230, 1925, 339, 1325, 1633, 596, 1784, 464, 796, 1928, 1025, 292, 1669, 1697, 708, 1, 1760, 1452, 346, 961, 1172, 354, 416, 363, 582, 161, 569, 922; 2. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)1123, (01)00884838059030(21)932, (01)00884838059030(21)239, (01)00884838059030(21)360, (01)00884838059030(21)500, (01)00884838059030(21)794, (01)00884838059030(21)939, (01)00884838059030(21)921, (01)00884838059030(21)286, (01)00884838059030(21)1440, (01)00884838059030(21)1144, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)107, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)656, (01)00884838059030(21)1261, (01)00884838059030(21)1170, (01)00884838059030(21)585, (01)00884838059030(21)1128, (01)00884838059030(21)882, (01)00884838059030(21)1230, (01)00884838059030(21)280, (01)00884838059030(21)488, (01)00884838059030(21)787, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)190, (01)00884838059030(21)1181, (01)00884838059030(21)694, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)1149, (01)0

Company location

Best

Recall type

Voluntary: Firm initiated

Recall number

Z-2259-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2259-2026 in the FDA Enforcement Report. Also see FDA recall press releases.