FDA Device recall Z-1177-2024
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mode…
- FDA Device
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mode… 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-1177-2024 |
| 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 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228
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: 722227 SN: UDI: 75 (01)00884838099227(21)75 122 (01)00884838099227(21)122 131 (01)00884838099227(21)13…OUS (1) Model: 722227 SN: UDI: 75 (01)00884838099227(21)75 122 (01)00884838099227(21)122 131 (01)00884838099227(21)131 132 (01)00884838099227(21)132 165 (01)00884838099227(21)165 116 (01)00884838099227(21)116 136 (01)00884838099227(21)136.' (2) Model: 722228 Serial Number UDI 168 (01)00884838099234(21)168 197 (01)00884838099234(21)197 154 (01)00884838099234(21)154 193 (01)00884838099234(21)193 165 (01)00884838099234(21)165 163 (01)00884838099234(21)163 139 (01)00884838099234(21)139 202 (01)00884838099234(21)202 141 (01)00884838099234(21)141 200 (01)00884838099234(21)200 174 (01)00884838099234(21)174 178 (01)00884838099234(21)178 147 (01)00884838099234(21)147 208 (01)00884838099234(21)208 171 (01)00884838099234(21)171 167 (01)00884838099234(21)167 194 (01)00884838099234(21)194 176 (01)00884838099234(21)176 228 (01)00884838086777(10)2.0.0.10015 161 (01)00884838099234(21)161 |
|---|
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-1177-2024%22
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