Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO Recalled by Physio-Control, Inc. Due to Due to an error message that prevents users...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Physio-Control, Inc. directly.
Affected Products
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 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.
Quantity: 622
Why Was This Recalled?
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Physio-Control, Inc.
Physio-Control, Inc. has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report