Philips recalls Azurion 3M12 models with specific software versions due to dark images that may not be clinically usable after pedal taps during Roadmap Pro use.
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 3M12 medical imaging devices with certain software versions. The issue can cause dark images that aren't clinically usable after a brief pedal tap during a procedure, potentially affecting diagnostic accuracy.
During Roadmap Pro software updates, pressing the footswitch pedal briefly (without generating an X-ray) can cause a dark image in the next fluoroscopy run. This dark image may not be clinically usable, potentially leading to incorrect diagnoses if the issue occurs during a procedure.
Medical professionals using Philips Azurion 3M12 systems with model numbers 722063 or 722221 and specific software versions are most at risk. Patients receiving imaging procedures with these devices may be affected if the dark images impact diagnosis.
Check if your Philips Azurion 3M12 has model numbers 722063 or 722221 and software releases R2.2.0 through 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 or in the user manual.
The recall is due to a software issue in Roadmap Pro that can cause dark images after a brief pedal tap during fluoroscopy, which may not be clinically usable.
Your device is affected if it has model numbers 722063 or 722221 and software releases R2.2.0 through R2.2.6, as listed in the recall notice.
No, the recall does not require immediate discontinuation. Users can continue using the device but should check for dark images after pedal taps and report issues to Philips.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2284-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2284-2026 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.
