The FDA has posted 11 enforcement recalls of patient (without arrhythmia detection or alarms) physiological monitor devices since 2025, none of them Class I (most serious). Most recent report: Sep 30, 2026.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
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.
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.