The company issued the recall due to certain Rad-G devices powering off and on without pressing the power button. Masimo said the issue can result in an unintentional change in the device’s power state.
According to a company warning letter to customers, a loss of monitoring could happen if the device powers off unexpectedly, resulting in a potential delay in patient care.
Masimo has received 529 complaints related to this issue, with an occurrence rate of 3%. Two patient deaths have been reported while being monitored with the Rad-G devices. The company has not determined whether the devices powered off unexpectedly.
Masimo’s mitigation
The company recommends healthcare providers assess their inventory to confirm if they have the affected Rad-G devices and remove them from use.
Customers should also contact Masimo Technical Services to request repair or replacement of the affected part and serial numbers. Masimo also requests customers acknowledge receipt of the warning and return the customer warning notice.
More about the Rad-G pulse oximeter
The Rad-G provides clinically proven SET pulse oximetry, respiration rate from the pleth (RRp), and other vital parameters for both spot-checking and continuous monitoring, according to Masimo. It won FDA clearance in September 2020.
Other product descriptions and claims from Masimo include a long-lasting rechargeable battery, robust rubber casing, and lightweight. There’s also the new multipurpose, direct-connect Rad-G Sensor sensor for both adults and children.
The goal is to make it easier for clinicians to quickly assess patients and make informed care decisions anywhere pulse oximetry or vital signs checking is needed in a compact, portable form factor. The Rad-G can be used in a variety of settings, including physicians’ offices, outpatient services, long-term care facilities, wellness clinics, first-response scenarios, limited-resource environments and more.
