January 14, 2020

Royal Philips issues urgent safety alert for fluoroscopy system

By: Judy Mathias

Editor's Note

Royal Philips has issued an urgent field safety notice for its CombiDiagnost R90 GCF fluoroscopy system, the January 10 MassDevice reports.

When the tilting feature is used, the device could be locked in a “Table Up/Down” state, an issue that could result in the entry of contrast agent into the brain, causing a headache until the patient is removed from the system.

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In addition, the thermo switch of the system power distribution unit may not function correctly, which could lead to the device overheating and generating smoke.

The company plans to install a software update and perform on-site checks of the systems to eliminate the issues.


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