The FDA has posted 13 enforcement recalls of patient (without arrhythmia detection or alarms) physiological monitor devices since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI…
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 .
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.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
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.
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)”). Informational only — verify against the FDA before acting.