Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 52 recalls
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate;…
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
Antivirus software was not consistently installed on impacted devices during the implementation process.
Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion…
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispens…