Reported Feb 26, 2025 · Ongoing
LIFEPAK 15 V4/Masimo Rainbow Sensors
Physio-Control, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Physio-Control, Inc. · 11811 Willows Rd Ne · Redmond, WA · 98052-2003
Is this the product you have?
LIFEPAK 15 V4/Masimo Rainbow Sensors
3 of 3 products
| Model / number | Product as published |
|---|---|
11996-000515 | Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor |
11996-000519 | Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor |
11996-000520 | The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. |
- Amount recalled
- 622
Where it was sold
Why it was recalled
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
This product could cause temporary or reversible health problems — stop using it.
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