Masimo Rad-G Pulse Oximeter Recall: Potential Automatic Power Loss
Masimo Corporation is recalling 443 Rad-G pulse oximeters that may automatically power off and on, interrupting patient monitoring. Affected units are 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 FDA Class II recall involves a medical device that may lose monitoring function. While no illnesses or injuries are reported in the source, the potential for loss of monitoring in medical settings represents a risk of harm.
Plain-English summary
Masimo Corporation is recalling Masimo Rad-G pulse oximeters with temperature sensors (model REF:9210) due to a potential defect. A total of 443 units have been identified as affected.
The recalled devices may automatically power off and on unexpectedly, which can result in loss of patient monitoring. This interruption in device function could prevent continuous oximetry monitoring.
The affected units have been distributed throughout the United States and internationally to countries including Canada, the United Kingdom, Germany, France, Japan, Australia, India, and others. Healthcare providers and individual users should check the provided serial numbers to determine if their device is affected.
Users with affected devices should stop using them and contact Masimo Corporation for replacement or repair instructions. Serial numbers listed in the official recall notice can be used to identify affected units.
The recalled product
- Product
- Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,
- Manufacturer
- Masimo Corporation
- Category
- Medical Device — Pulse Oximeter
- Hazard
- power-cycling
- monitoring-loss
Distribution
Distributed nationwide across the United States.
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