United StatesPhilips Allura Xper interventional imaging systems are affected, including models FD10C (722001), FD10F (722002), FD10 (722003, 722010, 722026), FD10/10 (722005, 722011, 722027), FD20 (722006, 722012, 722028, 722029), FD20 Biplane (722008, 722013) and FD20 OR Table (722023), with specific serial numbers listed in the notice. Philips found that in a limited number of systems a drip tray beneath the cooling unit was not installed or not documented, which could allow coolant to contact electrical components, cause electrical short‑circuits, blow fuses and result in system shutdown.
What's being recalled
Product Name: Allura Xper FD10C; Model number: 722001;
Allura Xper FD10F; Model Number: 722002;
Allura Xper FD10; Model Number: 722003;
Allura Xper FD10/10; Model Number: 722005;
Allura Xper FD20; Model Number: 722006;
Allura Xper FD20 Biplane; Model Number: 722008;
Allura Xper FD10; Model Number: 722010;
Allura Xper FD10/10; Model Number: 722011;
Allura Xper FD20; Model Number: 722012;
Allura Xper FD20 Biplane; Model Number: 722013;
Allura Xper FD20 OR Table; Model Number: 722023;
Allura Xper FD10; Model Number: 722026;
Allura Xper FD10/10; Model Number: 722027;
Allura Xper FD20; Model Number: 722028;
Allura Xper FD20/10; Model Number: 722029;
And 1 more products.
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
Model Number: 722001; System Product Name: Allura Xper FD10C; UDI-DI: N/A; Serial Numbers: 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, 299, 30, 235, 221, 348, 283, 276, 253, 1100, 78, 229, 232, 159, 177, 219, 217, 205, 3, 89, 101, 295, 305; Model Number: 722002; System Product Name: Allura Xper FD10F; UDI-DI: N/A; Serial Numbers: 61, 56, 27, 81, 25, 85, 20, 21, 84, 50, 31, 40; Model Number: 722003; System Product Name: Allura Xper FD10; UDI-DI: N/A; Serial Numbers: 1232, 967, 746, 1276, 232, 385, 1663, 1189, 81, 700, 167, 1072, 994, 150, 135, 1268, 168, 855, 213, 60, 471, 153, 319, 1159, 162, 180, 142, 1205, 719, 926, 426, 1413, 798, 65, 1165, 1658, 1193, 1778, 2933, 1585, 1380, 1706, 1613, 1685, 1297, 1388, 1522, 1238, 1416, 1448, 536, 1090, 1662, 1083, 1433, 1399, 62, 943, 249, 1227, 163, 1121, 1119, 889, 861, 1649, PP0200000118, 804, 1527, 468, 1593, 1198, 1022, 708, 1054, 865, 744, 1760, 936, 782, 953, 1035, 1058, 179, 1254, 1112, 389, 1560, 1660, 1013, 25, 215, 27; Model Number: 722005; System Product Name: Allura Xper FD10/10; UDI-DI: N/A; Serial Numbers: 93, 269, 530, 306, 307, 247, 53, 401, 141, 531, 184, 75, 276, 36; Model Number: 722006; System Product Name: Allura Xper FD20; UDI-DI: N/A; Serial Numbers: 1370, 1376, 225, 249, 1273, 1496, 707, 1466, 1141, 1201, 359, 105, 285, 1433, 822, 1747, 318, 797, 124, 1518, 384, 1045, 328, 302, 1536, 514, 910, 2123, 1360, 1381, 149, 379, 387, 1733, 197, 314, 888, 189, 310, 209, 863, 325, 378, 2110, 166, 118, 1978, 304, 1696, 2524, 248, 1928, 294, 804, 1227, 56, 245, 1560, 1795, 902, 1295, 1123, 1424, 1958, 40, 1222, 1947, 2289, 1687, 2304, 666, 2086, 958, 1801, 2546, 1317, 1478, 589, 2154, 1557, 1580, 519, 273, 157, 1504, 836, 1365, 393, 2428, 1902, 2433, 1521, 115, 2023, 1003, 1509, 1494, 2171, 2391, 867, 1513, 29, 951, 1814, 284, 482, 455, 1763, 1899, 1968, 837, 856, 1537, 93, 1561, 1746, 1232, 430, CV.797, 1974, 507, 1949, 1275, 1427, 1967, 374, 116, CV.507, 7567201, 2225, 267…
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
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