FDA Device recall Z-1351-2026
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only)
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only) by Philips Medical Systems Nederland B V, citing under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1351-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-26 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Reason
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Identifiers
| code_info | System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); UDI-DIs: (1)884838099234, (2)884838116757, (3)N/A; Serial Numbers: All; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1351-2026%22
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