FDA Flags Three Infusion Pump Corrections from Smiths Medical as Class I Recalls
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
Issues may cause therapy delays, false alarms, or thermal damage, though no injuries reported to date.
Through its distribution partnership with Encore Medical Device Repair, Restore Robotics can deliver the remanufactured instruments to hospitals and surgical centers across the US.
Abiomed has updated the use instructions for its Impella RP pumps due to a risk of device interaction that could damage the optical sensor or temporarily stop the pump.
The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.
Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.
Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.
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.