Category: FDA Updates

FDA Updates

FDA Issues Safety Alert for Philips CPAP Machine

The FDA issued a safety communication to the public on reports involving thermal issues with a Philips Respironics CPAP machine.

FDA Updates

FDA Clears AQUAbase nX Reverse Osmosis System

B. Braun has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AQUAbase nX Reverse Osmosis System.

FDA Updates

Quanta Dialysis System Submitted to FDA for Clearance

Quanta Dialysis Technologies has submitted a 510(k) premarket notification to the FDA for indication expansion of the Quanta Dialysis System.

Clearances

Xenex LightStrike+ Disinfection Robot Granted FDA Authorization

Xenex was granted De Novo FDA authorization for the LightStrike+ device, a high-intensity, broad-spectrum UV light robot.

Recalls

Hamilton Medical Inc. Recalls Ventilators Due to Critical Software Issue

Hamilton Medical Inc. has issued a Class I recall, the most serious category, for Hamilton-C1, C2, C3, and T1 ventilators due to a critical software glitch that can abruptly halt operation after 91 days without restarting.

Labeling

Labeling Update Issued for Certain Bronchoscopes Used with Lasers

A company has announced a voluntary field corrective action to address complaints of endobronchial combustion occurring when laser-compatible bronchoscopes are used during therapeutic procedures.

Draft Guidances

FDA Issues Draft Guidance on Remanufacturing, Seeks Feedback on Cybersecurity Servicing of Medical Devices

The U.S. FDA is now accepting comments from the public on the draft guidance, “Remanufacturing of Medical Devices,” and on a discussion paper on cybersecurity servicing of devices.