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FDA (Device enforcement)Recalled 2024-08-06class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

Hazard

The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel.

Details from the source

Reason for recall: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Distribution: Worldwide - US Nationwide distribution. Quantity: 927 systems Lot/code info: UDI-DI: (01)00884838085268 (01)00884838099258; Serial Numbers: 261 277 1257 2770 1316 3067 703615 2929 2675 139 159 703335 1018 703497 2727 1170 2957 266 1160 766 2156 1615 1637 1651 1657 1925 643 370 637 331 2793 1405 588 2241 2325 2326 2327 1278 740 747 851 852 1040 88 447 2278 1164 866 1063 1459 119 1213 1985 813 814 409 3120 2995 703419 2972 1994 1082 2390 138 895 1201 1234 1102 865 1554 2952 2549 1283 2448 2220 823 824 1258 2511 626 901 1571 2906 2918 2996 703486 2030 1024 1346 1347 1003 850 338 2636 1940 113 2145 644 580 2981 49 39 753 434 583 968 2177 335 1143 2831 703584 738 703350 847 327 1223 954 192 1046 2280 134 301 1064 461 1361 703420 252 441 479 2764 403 1931 433 1265 217 2121 526 2311 1363 1364 1365 3153 925 422 1037 1739 826 1917 871 873 1781 1929 2435 1005 278 2229 2246 2247 2248 1376 1377 1514 1702 1264 797 428 351 1960 101 401 482 120 1245 1086 1235 300 617 618 1436 540 329 328 1233 1235 1240 166 518 522 523 1336 307 592 1935 2340 1458 1049 2368 2567 1111 2453 999 862 897 2965 2967 979 1250 1879 940 2759 2027 475 755 215 1605 1392 1204 703508 974 2419 2420 216 1955 1041 2506 176 1289 869 2970 1158 130 1322 2152 3038 453 893 380 2201 1112 2913 1650 750 41 2687 1084 1838 2195 2196 945 2370 1266 958 3152 483 484 703408 395 845 469 2172 1430 703368 703562 417 432 439 516 630 645 770 1309 1310 1371 1614 1934 2765 1395 566 1706 723 1982 787 267 268 788 789 478 346 1431 1244 1245 131 1117 831 2856 1150 3063 909 735 2647 1315 1484 40 731 1083 1444 1517 2903 2907 1

UPC codes

00884838085268, 00884838099258

Source

Official record: FDA (Device enforcement)

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

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