PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD.

Recalling company

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.

Reason

Firmware issue potentially leading to loss of geometry movements.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jun 29, 2026

Reported

Aug 19, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Uzbekistan, Vietnam, Yemen.

Status

Ongoing

Quantity

4,252 units

Lot / codes

Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)00884838054196(21)230, (01)00884838054202(21)596, (01)00884838054202(21)1957, (01)00884838054202(21)110, (01)00884838054202(21)2261, (01)00884838054189(21)1132, (01)00884838054226(21)115, (01)00884838059115(21)259, (01)00884838054202(21)173, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838059115(21)203, (01)00884838054202(21)1043, (01)00884838054189(21)458, (01)00884838054202(21)466, (01)00884838054226(21)42, (01)00884838054202(21)1077, (01)00884838059115(21)373, (01)0088483805420

Company location

Best

Recall type

Voluntary: Firm initiated

Recall number

Z-2928-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2928-2026 in the FDA Enforcement Report. Also see FDA recall press releases.