FDA Device recall Z-2134-2025
Azurion 7 M20
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Azurion 7 M20 by Philips Medical Systems Nederland B V, citing potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2134-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-04 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Reason
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
Identifiers
| code_info | System Model No. 722079; UDI: 00884838085268; Serial No. 525, 584, 587, 613, 631, 658, 708, 774, 777, 793, 800, 801, 83…System Model No. 722079; UDI: 00884838085268; Serial No. 525, 584, 587, 613, 631, 658, 708, 774, 777, 793, 800, 801, 838, 842, 843, 862, 865, 866, 879, 881, 896, 899, 900, 905, 908, 909, 912, 915, 923, 925, 930, 939, 948, 955, 957, 992, 750, 814, 321, 370, 549, 567, 670, 687, 688, 693, 707, 743, 759, 767, 768, 775, 785, 786, 791, 819, 855, 871, 872, 902, 916, 917, 933, 936, 956, 960, 963, 965, 966, 969, 977, 993. |
|---|
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-2134-2025%22
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