FDA Device recall Z-2476-2021
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, int…
- FDA Device
- Class II
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, int… by Philips North America, citing early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2476-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-13 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Reason
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
Identifiers
| code_info | Serial number: 921 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2476-2021%22
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