Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 12 recalls
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Due to complaints, software update may cause software to unexpectedly shutdown.
Due to complaints, software update may cause software to unexpectedly shutdown.
Medical device software marketed without FDA clearance .
Medical device software marketed without FDA clearance .
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.