FDA aware of Philips Lumify ultrasound safety issue after 4 deaths, 8 serious injuries reported

The FDA says it is aware that Philips Ultrasound has sent a letter to customers recommending updated use instructions for all Lumify diagnostic ultrasound systems. According to Philips, due to a software issue, the Lumify app may require unexpected transducer re-registration. As of Sept 29, Philips reported 8 serious injuries and 4 deaths associated with the issue.

Detected & updated continuously · Source: Nebula

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Philips UltrasoundFood and Drug Administration

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