Official recall record
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro
- 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)
- 00884838099265
- 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.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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 →
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