Recall Z-2928-2026
Philips Medical Systems Nederland B.V. · initiated June 29, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Codes / lots: 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…
Reason for recall
Firmware issue potentially leading to loss of geometry movements.
FDA-determined cause: Software design
Action taken
Philips notified consignees on about 06/29/2026 via certified mailed letter titled URGENT Medical Device Correction. Consignees were provided instructions to properly identify affected systems and table configurations, instructions for restarting the geometry when the issue occurs, to ensure the notification is distributed to all relevant users and retained with device documentation until corrective actions are completed. Consignees were also instructed to post the notification letter near affected devices for ease of reviewing, notify recipients if affected units were transferred, and to complete and return the provided response form. A Local Philips representative will contact consignees to schedule a visit for the implementation of the software update once available. Philips will address the identified issues by implementing a software update (R8.2.102.1) in all affected systems (FCO72200674). Philips currently expects R8.2.102.1 to be available by Q1 2027, subject to regulatory clearance.
Details
- Recall number
- Z-2928-2026
- Initiated
- June 29, 2026
- Posted by FDA
- August 10, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 4,252 units
- 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…
- Recalling firm
- Philips Medical Systems Nederland B.V., Best