Philips recalls Azurion 5M12 models with specific software versions due to dark images appearing after pedal taps, 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 Azurion 5M12 medical imaging devices with certain software versions. The issue causes dark images that aren't clinically usable after a quick pedal tap during use, potentially affecting image quality for medical procedures.
The device may show a dark image that isn't clinically usable after a user briefly taps the footswitch pedal without generating an X-ray image. This can happen during the Roadmap Pro software phase and may affect the next fluoroscopy run.
Medical professionals using Philips Azurion 5M12 systems with model number 722227 and specific software versions are most at risk. Patients receiving imaging with these devices may also be affected.
Check for model number 722227 with software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6. The device also has specific UDI codes listed in the recall notice.
Verify your device's software version by checking the model number and software releases listed in the recall notice.
The recall is due to dark images that may not be clinically usable after a pedal tap during use, which can affect the next fluoroscopy run.
Check for model number 722227 with software releases R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6, or specific UDI codes listed in the recall notice.
No, the recall does not require stopping use immediately. The hazard is low risk and does not cause serious injury.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2286-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2286-2026 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.
