FDA DevicesClass II
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0...
Published: June 10, 2026Recall ID: Z-2284-2026Category: 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 3M12, Model Numbers: 722063, 722221 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)00884838099203(21)3, (01)00884838099203(21)7, (01)00884838085275(21)131, (01)00884838099203(21)54, (01)00884838085275(21)84, (01)00884838099203(21)6, (01)00884838099203(21)93, (01)00884838085275(21)132, (01)00884838099203(21)69, (01)00884838099203(21)9, (01)00884838099203(21)115, (01)00884838099203(21)85, (01)00884838099203(21)19, (01)00884838099203(21)49, (01)00884838099203(21)108, (01)00884838085275(21)108. |
| Postal code | N/A |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 16 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.