Masimo Recalls Rainbow Reusable Sensors Due to Inaccurate Readings
Masimo is recalling Rainbow Reusable Sensors because incompatible configurations may cause no readings or inaccurate SpCO and SpMet results.
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: The recall involves a medical device that may provide inaccurate readings for critical parameters (SpCO and SpMet), which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Masimo Corporation is recalling specific models of Rainbow Reusable Sensors, including the RAINBOW DCI-DC3, DCI-dc8, DCI, and DCIP, PED. These sensors are indicated for spot check or continuous non-invasive monitoring of arterial saturation (SpO2), arterial carboxyhemoglobin saturation (SpCO), arterial methemoglobin (SpMet), and pulse rate.
The recall is due to sensors being manufactured with incompatible configurations. This defect could result in the sensors providing either no readings or inaccurate readings for the SpCO and SpMet parameters.
A total of 3,476 units are affected, with 3,322 units distributed in the United States. The remaining units were distributed internationally to Australia, Costa Rica, France, Germany, Kuwait, Martinique, Netherlands, Norway, South Korea, and Turkey. Users should stop using the affected sensors and contact Masimo Corporation for instructions on replacement or refund.
The recalled product
- Product
- rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check o
- Manufacturer
- Masimo Corporation
- Category
- Medical Device — Pulse Oximetry
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2201 2407 2696 2697
Distribution
Distributed nationwide across the United States.
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