FDA Device recall Z-1156-2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected syst…
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected syst… by Philips Medical Systems Nederland B V, citing dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1156-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-02 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)
Reason
Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
Identifiers
| code_info | Allura Xper FD10 722003 - no UDI Serial Numbers 105 1181 1209 1349 1435 1472 1529 1555 1594 1700 1719 1788 285 472 482…Allura Xper FD10 722003 - no UDI Serial Numbers 105 1181 1209 1349 1435 1472 1529 1555 1594 1700 1719 1788 285 472 482 912 913 928 , 722010 - UDI-DI 00884838059030 or 00884838059191 Serial Numbers 1005 1009 1011 1025 1028 1040 1041 1042 1043 1048 1064 1069 107 1078 1082 1084 1108 1109 1112 1118 1123 1126 1128 1132 1144 1149 1170 1173 1176 1181 1183 1209 1210 1214 1226 1230 1233 1234 1235 1236 1244 1261 1263 1275 1279 1283 1287 1292 1297 1298 1302 1308 1309 1310 1312 1328 133 1336 1344 1347 1369 1370 1373 1391 1395 1396 1397 1398 1424 1436 1440 1442 145 170 177 191 209 214 252 314 33 337 343 344 39 414 43 467 468 477 480 500 527 572 585 604 609 61 611 624 646 65 651 656 662 667 668 670 679 68 714 728 754 755 763 767 791 794 809 818 830 838 839 873 882 896 902 905 914 917 920 921 931 932 937 939 946 965 968 970 976 979 986 987 992 999 , 722026 - UDI-DI 00884838054189 Serial Numbers 100 101 102 1050 1052 1068 109 11 110 112 114 115 116 117 1205 121 1210 122 130 142 151 155 156 185 190 191 |
|---|
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-1156-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.