Philips recalls Azurion 7B20/15 models with specific software versions due to dark images appearing after pedal taps during fluoroscopy runs.
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.
Philips is recalling certain Azurion 7B20/15 medical imaging devices that may show dark images after a quick pedal tap. This could lead to non-clinically usable images during procedures, but the risk is not immediately dangerous to users.
The device may produce a dark image that is not clinically usable after a user performs a pedal tap (a brief touch of the footswitch pedal without generating an X-ray image). This dark image can occur during the next fluoroscopy run, potentially affecting image quality and procedure outcomes.
Medical professionals using Philips Azurion 7B20/15 systems with specific model numbers and software versions are most at risk. Patients using these systems may experience non-clinically usable images during procedures.
Check if your Philips Azurion 7B20/15 has model numbers 722068 or 722226 and software releases R2.2.0 through R2.2.6. The UDI codes listed in the recall notice also identify affected units.
Verify your device's software version by checking the model numbers and software releases listed in the recall notice.
No, the recall does not pose an immediate safety risk. The issue is that images may not be clinically usable after a pedal tap, but it does not cause injury or damage to users.
Check if your device has model numbers 722068 or 722226 and software releases R2.2.0 through R2.2.6. The UDI codes listed in the recall notice also identify affected units.
The recall does not require immediate action. Check your device's software version and model numbers to determine if it is affected. If affected, contact Philips for further instructions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2289-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2289-2026 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
