FDA Device recall Z-2291-2026
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So…
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro So… by Philips Medical Systems Nederland B V, citing during the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2291-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-07 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Identifiers
| code_info | UDI (01)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)008…UDI (01)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)00884838099258(21)275, (01)00884838099258(21)277, (01)00884838099258(21)295, (01)00884838099258(21)272, (01)00884838099258(21)261, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838099258(21)1315, (01)00884838099258(21)381, (01)00884838099258(21)959, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838085268(21)460, (01)00884838085268(21)1387, (01)00884838099258(21)260, (01)00884838099258(21)1019, (01)00884838099258(21)1371, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838099258(21)1049, (01)00884838099258(21)1484, (01)00884838099258(21)1083, (01)00884838085268(21)703307, (01)00884838099258(21)246, (01)00884838099258(21)475. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2026%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.