Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–28 of 28 recalls
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery.…
An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.