FDA DevicesClass II
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2....
Published: June 10, 2026Recall ID: Z-2285-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Philips Azurion 3M15, Model Numbers: 722064, 722222 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
Affected Products
Philips Azurion 3M15, Model Numbers: 722064, 722222 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
Additional Source Details
| Field | Value |
|---|---|
| City | Best |
| Event id | 98977 |
| Address 1 | Veenpluis 6 |
| Code info | UDI (01)00884838085282(21)209, (01)00884838099210(21)100, (01)00884838099210(21)254, (01)00884838099210(21)256, (01)00884838099210(21)257, (01)00884838099210(21)265, (01)00884838099210(21)255, (01)00884838099210(21)99, (01)00884838085282(21)260, (01)00884838085282(21)261, (01)00884838099210(21)69, (01)00884838099210(21)12, (01)00884838085282(21)314, (01)00884838085282(21)259, (01)00884838099210(21)15, (01)00884838099210(21)19, (01)00884838099210(21)23, (01)00884838099210(21)17, (01)00884838085282(21)258, (01)00884838099210(21)55, (01)00884838099210(21)45, (01)00884838085282(21)270, (01)00884838099210(21)187, (01)00884838099210(21)223, (01)00884838099210(21)44, (01)00884838099210(21)113, (01)00884838099210(21)112. |
| Postal code | N/A |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 27 units |
| Reason for recall | 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. |
| Recall initiation date | 20231207 |
| Initial firm notification | Letter |
| Center classification date | 20260601 |
Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.