Philips Allura interventional fluoroscopy recall affects nearly 10,000 U.S. systems over imaging, movement, and data loss issues

Philips has issued an urgent correction for its Allura interventional fluoroscopy systems due to imaging capture malfunctions, loss of motorized movement, and unauthorized hard drives, affecting nearly 10,000 U.S. units. Manual repositioning workarounds exist; no adverse events…

• Philips issued Urgent Medical Device Correction letters in June, providing manual repositioning instructions (handgrips, brake controls) to maintain use until scheduled repairs.
• The class 2 recall stems from unauthorized hard disk drives that can cause imaging capture failures and motorized movement loss; nearly 10,000 units are impacted but no injuries have been reported.
• Starting in September, Philips will inspect all systems, replace hard drives, and correct mixed disk configurations.

Automated summary

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