Physio-Control, Inc.: Device Recall

Recall #Z-1184-2025 · 01/21/2025

Class II: Risk

Recall Details

Recall Number
Z-1184-2025
Classification
Class II
Product Type
Device
Recalling Firm
Physio-Control, Inc.
Status
Ongoing
Date Initiated
01/21/2025
Location
Redmond, WA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
622

Reason for Recall

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

Product Description

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.

Distribution Pattern

U.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MS, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WV.

Other Recalls by Physio-Control, Inc.

View all recalls by Physio-Control, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.