Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 1611 1423 177 3039 703307 279 1252 1519 832 703450 2131 1091 703528 1374 1375 1939 1004 1102 2288 467 468 539 2421 128 400 1006 1098 730 364 703345 1276 1309 1493 1032 1527 2900 726 1288 963 965 552 1381 1382 1156 839 254 1403 440 1382 246 2184 2436 1959 613 713 741 1461 1508 1511 1512 967 1059 2963 859 987 993 994 1081 1103 1391 703389 2449 1043 2502 1808 1314 1200 1222 703379 703402 777 956 485 572 2144 2148 1118 1063 1249 1337 571 174 262 275 295 272 665 1230 36 1483 715 1662 178 1663 253 1228 1220 703305 703360 1410 90 1995 1270 1274 2859 2619 2620 1221 2504 2198
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Product Codes/Lot Numbers:
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 1611 1423 177 3039 703307 279 1252 1519 832 703450 2131 1091 703528 1374 1375 1939 1004 1102 2288 467 468 539 2421 128 400 1006 1098 730 364 703345 1276 1309 1493 1032 1527 2900 726 1288 963 965 552 1381 1382 1156 839 254 1403 440 1382 246 2184 2436 1959 613 713 741 1461 1508 1511 1512 967 1059 2963 859 987 993 994 1081 1103 1391 703389 2449 1043 2502 1808 1314 1200 1222 703379 703402 777 956 485 572 2144 2148 1118 1063 1249 1337 571 174 262 275 295 272 665 1230 36 1483 715 1662 178 1663 253 1228 1220 703305 703360 1410 90 1995 1270 1274 2859 2619 2620 1221 2504 2198
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2953-2024
Related Recalls
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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. Expansion to add additional model.
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.