Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Masimo
11 recalls • • Categories: Diagnostic Equipment, Other Medical Devices, Implants & Prosthetics
Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Class I - Dangerous
TC-I tip clip sensor may produce readings outside the accuracy specification.
Class I - Dangerous
TC-I tip clip sensor may produce readings outside the accuracy specification.
Class I - Dangerous
TC-I tip clip sensor may produce readings outside the accuracy specification.
Class I - Dangerous
TC-I tip clip sensor may produce readings outside the accuracy specification.
These sensors were manufactured with incompatible configurations. This could result in sensors that will provide either no readings or inaccurate readings for the SpCO and SpMet parameters.
Firm has identified a small number of Oximetry Cables with crossed-internal wires. The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device. Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.