Philips recalls Azurion 5M20 CT scanners with specific software versions due to dark images appearing after pedal taps during Roadmap Pro updates. Affected units may need software updates to prevent unusable images.
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 5M20 CT scanners with certain software versions because a pedal tap can cause dark images that aren't clinically usable. This issue may affect medical imaging results if not corrected.
When a user briefly touches the footswitch pedal without generating an X-ray image (a pedal tap), the device may produce a dark image in the next fluoroscopy run. This dark image isn't clinically usable and could lead to incorrect imaging results.
Medical facilities using Philips Azurion 5M20 CT scanners with model number 722228 and specific software versions are most at risk. Patients and staff using these scanners could see unusable images during procedures.
Check if your Philips Azurion 5M20 scanner has model number 722228 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 releases listed in the recall notice.
The recall is due to a software issue where a brief pedal tap can cause dark images that aren't clinically usable during Roadmap Pro updates.
Check if your Philips Azurion 5M20 has model number 722228 and software versions R2.2.0, R2.2.1, R2.2.3, R2.2.5, or R2.2.6.
No, the recall does not require immediate discontinuation. Affected devices can continue to be used with the software update provided by Philips.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2287-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-2287-2026 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.
