Philips recalls Azurion 3M15 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 Azurion 3M15 medical imaging devices with certain software versions. These devices may show 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.
Healthcare providers using Philips Azurion 3M15 systems with model numbers 722064 or 722222 and specific software versions are most at risk. Patients undergoing procedures with these devices may experience inaccurate imaging results.
Check if your Philips Azurion 3M15 has model numbers 722064 or 722222 and software versions R2.2.0 through R2.2.6. The device may also have unique identifiers listed in the UDI codes provided in the recall notice.
Identify your Philips Azurion 3M15 model number (722064 or 722222) and software version (R2.2.0 to R2.2.6).
Reach out to Philips customer support for guidance on whether your device is affected and next steps.
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 for model numbers 722064 or 722222 with software versions R2.2.0 through R2.2.6, or unique identifiers listed in the UDI codes provided in the recall notice.
No. The recall does not require immediate discontinuation; affected users should check their device details and contact Philips for guidance.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2285-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2285-2026 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.
