Philips recalls Azurion 7M12 models with specific software versions due to dark images appearing after pedal taps during fluoroscopy runs, which may not be clinically usable.
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 7M12 medical imaging devices with specific software versions. These devices may produce dark images that aren't clinically usable after a user taps the footswitch pedal without generating an X-ray image. This issue could affect medical procedures requiring accurate imaging.
The hazard occurs when a user briefly touches the footswitch pedal (pedal tap) without generating an X-ray image. This action can cause the next fluoroscopy run to display a dark image that isn't clinically usable, potentially leading to incorrect medical diagnoses.
Medical professionals using Philips Azurion 7M12 systems with the listed software versions are most at risk. Patients undergoing procedures with these devices may experience inaccurate imaging results.
Check if your Philips Azurion 7M12 has model numbers 722078 or 722223 and software releases R2.2.0 through R2.2.6. The device may also have the listed UDI codes.
Verify your device's software version by checking the device settings or documentation. If it matches the recalled versions (R2.2.0 to R2.2.6), it is affected.
The issue is that during the Roadmap Pro software phase, a pedal tap (briefly touching the footswitch pedal without generating an X-ray image) can cause the next fluoroscopy run to display a dark image that isn't clinically usable.
Check if your Philips Azurion 7M12 has model numbers 722078 or 722223 and software releases R2.2.0 through R2.2.6. The device may also have the listed UDI codes.
The recall does not specify a remedy, so no action is required beyond checking your device's software version.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2290-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2290-2026 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.
