Masimo Recalls Certain Rad-G Pulse Oximetry Devices

Masimo recently announced the recall of some of its Rad-G pulse oximeters after reports of unintended change of device power state.

Nabbing FDA clearance in September 2020, Rad-G is a portable SET pulse oximetry device that also measures other vital parameters like respiration rate from the pleth, oxygen saturation, pulse rate, perfusion index, and pleth variability index. The use of these measurements, according to Masimo, enables both spot checking and continuous monitoring to quickly assess patient condition.

The company is recalling certain Rad-G devices after it was identified that the devices were powering off and on without pressing the power button, which can result in sudden change in the power state. If this were to occur, it could result in loss of patient monitoring and potentially result in delayed patient care. Masimo reported that it has received a total of 529 complaints related to the issue — an occurrence rate of 3%. Additionally, there have been two reports of death while patients were being monitored with the device, however, it has not yet been determined whether Rad-G powered off unexpectedly in these cases.

After initially contacting affected customers on Feb. 15, 2024, Masimo is recommending healthcare providers assess inventory and, if affected Rad-G devices are found, remove them from use. Customers should contact Masimo Technical Services to request repair or replacement of affected parts and products.

Recalled serial numbers include:

Masimo did not reply to MD+DI’s request for comment.