FDAFDA · Food and drugs·Recall number Z-2286-2026
Philips Azurion 5M12, Model Numbers: 722227 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
Published June 10, 2026 · Recall initiated: December 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- US Nationwide distribution.
- Lot
- UDI (01)00884838099227(21)88, (01)00884838099227(21)135, (01)00884838099227(21)63.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.