Masimo Rad-G Pulse Oximeter automatic power cycling may cause monitoring loss
Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.
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 where the potential hazard—automatic power cycling causing loss of monitoring—poses serious risk of harm. Per the severity rubric, risk-of-harm medical devices without reported injuries are classified as High (score 3).
Plain-English summary
Masimo Corporation is recalling certain Masimo Rad-G pulse oximeters (REF:9849). These devices may automatically power off and on during operation, potentially resulting in loss of monitoring capability. Approximately 4978 units have been affected.
The recalled devices have been distributed worldwide, including throughout the United States. The devices are identified by specific serial numbers listed in the recall notice and the Universal Device Identifier (UDI) (01)00843997000666.
If you have one of the affected devices, verify the serial number against the recall list. Users with affected devices should stop using them and contact Masimo Corporation or their healthcare provider for instructions regarding device replacement or repair.
The recalled product
- Product
- Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
- Manufacturer
- Masimo Corporation
- Category
- Medical Device — Pulse Oximeter
- Affected units
- 4,978
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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