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FDAFDA · Food and drugs·Recall number Z-2928-2026

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

Published August 19, 2026 · Recall initiated: June 29, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Firmware issue potentially leading to loss of geometry movements.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distributor
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.
Lot
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)00884838054202(21)877, (01)00884838054202(21)896, (01)00884838054202(21)987, (01)00884838054202(21)995, (01)00884838054202(21)1343, (01)00884838054202(21)1439, (01)00884838059115(21)111, (01)00884838054202(21)895, (01)00884838054202(21)265, (01)00884838054202(21)305, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054196(21)1, (01)00884838054202(21)1154, (01)00884838054196(21)71, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)121, (01)00884838054189(21)436, (01)00884838054202(21)1716, (01)00884838054202(21)1983, (01)00884838054202(21)784, (01)00884838054202(21)2061, (01)00884838054202(21)729, (01)00884838054189(21)1338, (01)00884838054202(21)1393, (01)00884838054189(21)1068, (01)00884838054189(21)233, (01)00884838054202(21)525, (01)00884838054202(21)1948, (01)00884838054202(21)1656, (01)00884838054189(21)78, (01)00884838054202(21)209, (01)00884838054202(21)825, (01)00884838054202(21)1461, (01)00884838054202(21)408, (01)00884838059115(21)38, (01)00884838054202(21)570, (01)00884838054202(21)218, (01)00884838054202(21)734, (01)00884838054202(21)1050, (01)00884838054202(21)1751, (01)00884838054202(21)454, (01)00884838054202(21)1428, (01)00884838054219(21)57, (01)00884838054189(21)432, (01)00884838054202(21)666, (01)00884838054219(21)7, (01)00884838054189(21)224, (01)00884838054202(21)488, (01)00884838054226(21)108, (01)00884838054202(21)1094, (01)00884838054202(21)169, (01)00884838059115(21)23, (01)00884838054202(21)2173, (01)00884838054202(21)1214, (01)00884838054202(21)52, (01)00884838054202(21)66, (01)00884838054202(21)493, (01)00884838054202(21)994, (01)00884838054202(21)373, (01)00884838059115(21)290, (01)00884838054202(21)1213, (01)00884838054226(21)173, (01)00884838054202(21)339, (01)00884838054202(21)234, (01)00884838054189(21)93, (01)00884838054189(21)796, (01)00884838054189(21)1072, (01)00884838054202(21)1836, (01)00884838054202(21)364, (01)00884838054202(21)982, (01)00884838054202(21)634, (01)00884838059115(21)124, (01)00884838054202(21)190, (01)00884838054202(21)818, (01)00884838054202(21)1394, (01)00884838054202(21)1396, (01)00884838054202(21)1646, (01)00884838054202(21)386, (01)00884838054226(21)119, (01)00884838054226(21)126, (01)00884838054202(21)1650, (01)00884838054189(21)543, (01)00884838054202(21)2275, (01)00884838054189(21)1248, (01)00884838054202(21)1058, (01)00884838054189(21)561, (01)00884838059115(21)274, (01)00884838054202(21)1353, (01)00884838054202(21)1466, (01)00884838054196(21)319, (01)00884838
Risk classification
Class II
Area (FDA)
device
Country
Netherlands

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