FDA Device recall Z-2403-2023
Azurion
- FDA Device
- Class II
- ongoing
- Published 2023-09-13
On 2023-09-13 the FDA classified a Class II recall of Azurion by Philips Medical Systems Nederland B V, citing A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2403-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-19 |
| Published | 2023-09-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion
Reason
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Identifiers
| code_info | Azurion series |
|---|
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-2403-2023%22
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