Masimo Rad-G Pulse Oximeter May Randomly Power Off, Causing Loss of Monitoring
Approximately 21,723 Masimo Rad-G pulse oximeters may randomly power off and on, causing temporary loss of patient monitoring. The FDA classified this as a Class II recall affecting devices distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—potential automatic power off/on causing loss of critical patient monitoring—represents a risk-of-harm medical device defect. Per the rubric, when the source explicitly states no illnesses/injuries have been reported and the hazard is theoretical, the score is at most 3 (High).
Plain-English summary
The Masimo Rad-G Pulse Oximeter with Sensor (REF:9847, Rx only) manufactured by Masimo Corporation is being recalled. Approximately 21,723 units with specific serial numbers are affected.
The device has a potential defect where it may automatically power off and on unexpectedly, resulting in loss of patient monitoring capability. This malfunction could temporarily interrupt vital sign monitoring during patient care.
The affected devices have been distributed worldwide, including across all 50 US states and US territories, as well as to 48 countries including Canada, Japan, Australia, and the United Kingdom. The specific serial numbers affected are documented in the recall notice.
Patients and healthcare providers using affected units should contact Masimo Corporation to verify if their device is included in this recall based on the serial number. Healthcare facilities should remove affected devices from clinical use and follow the manufacturer's instructions for replacement or repair.
The recalled product
- Product
- Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,
- Manufacturer
- Masimo Corporation
- Hazard
- power-malfunction
- loss-of-monitoring
- device-malfunction
Distribution
Distributed nationwide across the United States.
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