Philips recalls Azurion 7B12/12 models with specific software versions due to dark images appearing after pedal taps during Roadmap Pro use. Affected units may need software updates.
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 7B12/12 medical imaging devices that may show dark images after a quick pedal tap during Roadmap Pro software use. This could lead to non-clinically usable images affecting medical procedures.
The device may show a dark image after a user briefly touches the footswitch pedal without generating an X-ray image. This dark image can occur during the Roadmap Pro software phase and may not be clinically usable for medical procedures.
Medical professionals using Philips Azurion 7B12/12 systems with specific model numbers and software versions are most at risk. Patients may be affected if procedures require these devices.
Check for model numbers 722067 or 722225 with software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6. The device uses specific UDI codes listed in the recall notice.
Verify your software version by checking the device settings or documentation. The affected versions are R2.2.0, R2.2.1, R2.2.3, R2.2.5, and R2.2.6.
The recall occurs because the device may show a dark image after a pedal tap during Roadmap Pro software use, which could result in non-clinically usable images.
Check for model numbers 722067 or 722225 with software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6. The UDI codes listed in the recall notice also indicate affected units.
Yes, you should check your software version. If affected, contact Philips for a software update to resolve the issue.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2288-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2288-2026 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.
