Masimo Recalls Rad-8 Pulse Oximeters Due to Unintended Power-Off Defect
Masimo is recalling 42,908 Rad-8 pulse oximeters worldwide because a small percentage of devices may power off unexpectedly when the patient cable is moved.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.
Plain-English summary
Masimo Corporation is recalling 42,908 units of Rad-8 pulse oximeters and accessories. These devices are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The recall covers catalog numbers 9190, 9193, 9191, 9192, 9212, 9213, 9218, 9219, 9224, 9282, 9285, 2883, and 9194.
The recall was initiated because Masimo identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connectors that can power off without the operator pressing the power button when the connector is moved. This defect could result in the loss of monitoring data.
The affected devices were distributed worldwide, including the United States (nationwide), Africa, Asia, Australia/New Zealand, Europe, Canada, Latin America, and the Middle East/SW Asia. Users should contact Masimo Corporation for further instructions regarding the recall and potential replacement or repair of the affected units.
The recalled product
- Product
- Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
- Manufacturer
- Masimo Corporation
- Affected units
- 42,908
Distribution
Distributed nationwide across the United States.
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