PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allur

Hazard

The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.

Details from the source

Reason for recall: The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. Distribution: Domestic: Nationwide; International: Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Greece, Hong Kong, Hung Quantity: 3314 units (816 US, 2498 OUS) Lot/code info: Code Information: Allura: 1. Allura Xper FD10C; Model: 722001; UDI-DI: N/A; Serial Numbers: 170, 242, 267, 142, 206, 316, 9, 306, 103, 33, 220; 2. Allura Xper FD10F; Model: 722002; UDI-DI: N/A; Serial Numbers: 0, 81, 47; 3. Allura Xper FD10; Model: 722003; UDI-DI: N/A; Serial Numbers: 208, 392, 109, 45, 1953, 1471, 1551, 485, 152, 928, 501, 90, 1435, 81, 939, 160, 472, 1349, 439, 1958, 1525, 72, 1187, 912, 368, 328A, 37, 1286, 1223, 487, 1061, 833, 688, 317, 157, 639, 375, 420, 225, 1338, 614, 214, 230, 736, 64, 1090, 1094, 1932, 1531, 421, 984, 373, 313, 918, 602, 374, 750, 1934, 1751, 1661, 961, 791, 454, 868, 416, 1329, 241; 4. Allura Xper FD10; Model: 722010; UDI: (01)00884838059030(21)921, (01)00884838059030(21)1440, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1428, (01)00884838059030(21)1396, (01)00884838059030(21)298, (01)00884838059030(21)1432, (01)00884838059030(21)1425, (01)00884838059030(21)1398, (01)00884838059030(21)1397, (01)00884838059030(21)1391, (01)00884838059030(21)1395, (01)00884838059030(21)314, (01)00884838059030(21)1297, (01)00884838059030(21)946, (01)00884838059030(21)1424, (01)00884838059030(21)1244, (01)00884838059030(21)1122, (01)00884838059030(21)1198, (01)00884838059030(21)1421, (01)00884838059030(21)1423, (01)00884838059030(21)1438, (01)00884838059030(21)697, (01)00884838059030(21)1192, (01)00884838059030(21)1326, (01)00884838059030(21)402, (01)00884838059030(21)1148, (01)00884838059030(21)1439, (01)0088483805903

UPC codes

00884838059030, 00884838054189, 00884838059047, 00884838054196, 00884838059054, 00884838054202

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.