—#217842

Product

Allura Xper FD20; Model Number: 722012;

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K102005, K130638, K130842, K133292, K141979, K161563
Affected lot / code info: Model Number: 722012; System Product Name: Allura Xper FD20; UDI-DI: 00884838059054; Serial Numbers: 2942, 1515, 1189, 1594, 535, 1964, 2156, 2742, 2092, 1673, 1803, 1655, 2020, 1973, 2037, 1853, 2098, 1248, 1082, 1576, 1057, 1129, 646, 930, 1421, 462, 203, 627, 2005, 1428, 353, 288, 191, 1994, 1802, 156, 853, 1283, 1956, 2361, 1980, 872, 931, 1295, 2513, 1090, 1374, 468, 1822, 812, 1379, 1817, 1580, 1050, 309, 144, 1841, 1845, 1468, 558, 1968, 1959, 2168, 1168, 1562, 967, 2114, 47, 167, 2091, 2053, 604, 603, 217, 2918, 373, 850, 1820, 1821, 1619;

Why it was recalled

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

Root cause (FDA determination)

Other

Action the firm took

On December 15, 2025, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: a. Affected systems may continue to be used in accordance with their Instructions for Use (IFU). b. Circulate this letter to all users so that they are aware of the issue. Keep this letter with the documentation of the system until Philips inspects and, where needed, corrects your system. c. Establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. d. If you detect a burning odor, smoke, or fire originating from the R-cabinet in the technical room, immediately switch off the system s main power. Do not operate or use the system further. Follow your institution s emergency procedures. e. In case the affected system has been transferred to another organization, please send a copy of this letter to that organization and inform Philips about this transfer through your local Philips representative. f. Complete and return the attached response form to Philips promptly and no later than 30 days from receipt. g. Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, India, Italy, Japan, Kenya, Korea, Republic of, Malaysia, Mexico, Nepal, Netherlands, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen.

Timeline

Recall initiated: 2025-12-15
Posted by FDA: 2026-01-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217842. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.