FDA Device recall Z-2953-2024
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
- FDA Device
- Class II
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class II recall of Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224 by Philips Medical Systems Nederland B V, citing 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 beari….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2953-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-06 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
Reason
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.
Identifiers
| code_info | UDI-DI: (01)00884838085268 (01)00884838099258; Serial Numbers: 261 277 1257 2770 1316 3067 703615 2929 2675 139 159 70…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2953-2024%22
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