Category: FDA Updates

FDA Updates

FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices

Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.

FDA Updates

NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations

The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.

FDA Updates

FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller

The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.

Clearances

FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound

The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.

Recalls

FDA Issues Class I Recall for Ambu Manual Resuscitators

The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.

Labeling

Admetsys Blood Diagnostic System Made Breakthrough Device

Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.

Draft Guidances

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.