Official recall record
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 k
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-12-07
- Country of alert
- Netherlands
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00884838099227
- Brand on record
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-09-16.
Same barcode in other registries
The same EAN appears in 4 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-03-03 · US FDA — Medical Devices
Azurion 5 M12; System Code: (1)722227, (2)722231; - 2025-01-13 · US FDA — Medical Devices
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). - 2025-01-13 · US FDA — Medical Devices
Azurion 5 M12 System Code: (1) 722227 (2) 722231 - 2026-10-06 · US FDA — Medical Devices
Philips Azurion 5 M12. Model Number: 722227.
Other recalls from this brand
- 2026-10-06 · US FDA — Medical Devices
Philips Azurion 5 M20. Model Numbers: 722228, 722281. - 2026-10-06 · US FDA — Medical Devices
Philips Azurion S. Model Number: 722285. - 2026-10-06 · US FDA — Medical Devices
Philips Azurion 3 M12. Model Numbers: 722063, 722221.
All 90 official recall notices naming PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on this site →