Philips recalls nearly 11,000 Azurion fluoroscopy units over image quality, geometry glitches

Philips has issued a Class 2 recall of its Azurion R2.2.10 interventional fluoroscopic systems due to software glitches that could degrade image quality or cause loss of geometric movements, affecting nearly 11,000 units worldwide.

• The FDA posted a recall notice after Philips sent Urgent Medical Device Correction letters to customers in mid-July.
• Mitigation includes a cold restart for image degradation and an emergency stop/power-on sequence to restore geometry; a software update is forthcoming.

Automated summary

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