Masimo Rad-G Pulse Oximeter Recall: Risk of Automatic Power Loss
Masimo Corporation is recalling 65 Masimo Rad-G pulse oximeters due to a potential defect causing automatic power cycling that could result in loss of patient monitoring.
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 3/5 (High).
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: FDA Class II medical device recall of a critical patient monitoring device. While no illnesses or injuries have been reported, the potential for automatic power loss to interrupt monitoring poses a significant risk of patient harm.
Plain-English summary
Masimo Corporation is recalling the Masimo Rad-G pulse oximeter with patient cable (REF: 9895, Rx Only). This recall affects 65 units with specific serial numbers distributed worldwide.
The devices may automatically power off and on unexpectedly, resulting in loss of monitoring capability. As a critical patient monitoring device, unexpected power loss poses a significant patient safety risk.
Affected units have been distributed worldwide, including throughout the United States and to multiple countries internationally. Healthcare facilities and patients using affected serial numbers should immediately cease use and contact Masimo Corporation for further instructions.
Users should discontinue use of recalled devices and contact the manufacturer for replacement or alternative monitoring solutions. Healthcare providers should verify they do not have affected serial numbers in their facilities.
The recalled product
- Product
- Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,
- Manufacturer
- Masimo Corporation
- Affected units
- 65
Distribution
Part of a larger recall action
This product is one of 4 recalled by Masimo Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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