FDA Device recall Z-1178-2024
Azurion 7 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 7 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-1178-2024 |
| 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 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226
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 | US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)15…US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)1518 1317 (01)00884838099258(21)1317 1221 (01)00884838099258(21)1221 845 (01)00884838099258(21)845 974 (01)00884838099258(21)974 905 (01)00884838099258(21)905 (3) Model: 722225 227 (01)00884838099265(21)227 (4) Model: 722226 441 (01)00884838099272(21)441 398 (01)00884838099272(21)398 OUS: 179 (01)00884838099265(21)179 145 (01)00884838099265(21)145 223 (01)00884838099265(21)223 226 (01)00884838099265(21)226 232 (01)00884838099265(21)232 196 (01)00884838099265(21)196 159 (01)00884838099265(21)159 200 (01)00884838099265(21)200 234 (01)00884838099265(21)234 206 (01)00884838099265(21)206. 412 (01)00884838099272(21)412 425 (01)00884838099272(21)425 420 (01)00884838099272(21)420 355 (01)00884838099272(21)355 393 (01)00884838099272(21)393 407 (01)00884838099272(21)407 402 (01)00884838099272(21)402 527 (01)00884838099272(21)527 479 (01)00884838099272(21)479 509 (01)0088483809 |
|---|
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-1178-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.