FDA Device recall Z-1176-2024
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mod…
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mod… by Philips Medical Systems Nederland B V, citing generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1176-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-06 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280
Reason
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Identifiers
| code_info | OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66; SN: 91 (01)00884838099203(21)91; SN: 104 (01)0088483809925…OUS: (1) Model: 722221 SN: 66 (01)00884838099203(21)66; SN: 91 (01)00884838099203(21)91; SN: 104 (01)00884838099258(21)104, (2) Model: 722222 SN: UDI: 165 (01)00884838099210(21)165 183 (01)00884838099210(21)183 189 (01)00884838099210(21)189 182 (01)00884838099210(21)182 185 (01)00884838099210(21)185 159 (01)00884838099210(21)159 184 (01)00884838099210(21)184 190 (01)00884838099210(21)190 174 (01)00884838099210(21)174 177 (01)00884838099210(21)177 (3)Model: 722280 20 (01)00884838103276(21)20 |
|---|
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-1176-2024%22
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