Masimo SET uSpO2 Pulse Oximetry Cables Recalled for Crossed Wires
Masimo Corporation is recalling specific SET uSpO2 Pulse Oximetry Cables due to crossed internal wires that may cause the monitoring device to display inverted SpO2 values.
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: The recall is classified as FDA Class II, and the defect presents a risk of harm through inaccurate medical monitoring data, but no injuries or illnesses have been reported.
Plain-English summary
Masimo Corporation is recalling a small number of Masimo SET uSpO2 Pulse Oximetry Cables. These in-line cables are used to provide continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate when installed in compatible host systems.
The recall is due to a manufacturing defect where internal wires are crossed. This defect causes the monitoring device to display inverted SpO2 values; specifically, a low measured SpO2 value may be displayed as high, and a high measured SpO2 value may be displayed as low.
The affected units were distributed worldwide, including in the United States, Puerto Rico, and various international markets. Healthcare facilities and users should check their inventory against the specific part and lot numbers listed in the official recall notice to identify affected units.
The recalled product
- Product
- Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package…
- Manufacturer
- Masimo Corporation
- Category
- Medical Device — Pulse Oximetry
- Hazard
Distribution
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