Philips recalls Azurion 7M20 models with specific software versions due to potential dark images after pedal taps during fluoroscopy. Affected units may require 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 7M20 medical imaging devices with specific software versions. The issue can cause dark images that aren't clinically usable after a brief pedal tap during a procedure, potentially affecting image quality and diagnosis.
The hazard occurs when a user briefly taps the footswitch pedal without generating an X-ray image. This action can cause a dark image in the next fluoroscopy run, which may not be clinically usable. The issue is limited to specific software versions and does not cause physical harm.
Medical facilities using Philips Azurion 7M20 systems with model numbers 722079 or 722224 and software releases R2.2.0 through R2.2.6 are most at risk. Patients undergoing procedures with these devices may experience image quality issues.
Check if your Philips Azurion 7M20 has model numbers 722079 or 722224 and software versions R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6. The device may also have specific UDI codes listed in the recall notice.
Verify your device's software version by checking the model number and software release on the device's settings menu.
The recall is due to a potential dark image that isn't clinically usable after a brief pedal tap during a fluoroscopy run, which can occur with specific software versions.
Check if your Philips Azurion 7M20 has model numbers 722079 or 722224 and software releases R2.2.0 through R2.2.6, as listed in the recall notice.
The recall does not require immediate action; users should check their software version and contact Philips if they have the affected versions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2291-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2291-2026 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.
