FDA Device recall Z-2284-2023
Azurion 7 M20
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Azurion 7 M20 by Philips Medical Systems Nederland B V, citing the bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2284-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-12 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion 7 M20. X-ray Image guided Therapy System.
Reason
The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage.
Identifiers
| code_info | Model No.: 722079, 722224; UDI-DI: (01)00884838085268(21), (01)00884838099258(21); System Equipment Number: 69991047, 6…Model No.: 722079, 722224; UDI-DI: (01)00884838085268(21), (01)00884838099258(21); System Equipment Number: 69991047, 69991048, 71927518, 71929379, 71929381, 71929386, 71934809, 71935340, 71937626, 71939045, 71957323, 72045694, 72150041, 72173543, 72273457, 72312081, 72321356, 72327897, 72400707, 72414989, 72419144, 72426402, 72648857, 72719305, 72719820, 72721959, 72748229, 72771284, 72805530, 72933546, 73000862, 73003437, 73011242, 73051857, 73337310, 73337321, 73339454, 73340554, 73407813, 73461447, 73516696, 73581917, 73581968, 73616732, 73625357, 73633104, 73717291, 73861967, 74017556, 74020682, 74095702, 74154690, 74154691, 74155276, 74169049, 74227230, 74227231, 74238084, 74250404, 74288937, 74298715, 74369399, 74465159, 74517090, 74582619, 74592051, 74593412, 74608935, 74609935, 74610486, 74610632, 74611953, 74613538, 74620302, 74620341, 74697609, 74817549, 74879566, 74896878, 75215416, 75387595, 75390578, 75434973, 75551701, 75581576, 75610667, 75635433, 75714884, 75844170, 75 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2284-2023%22
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