Recall record at a glance
| Official record | Z-1184-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Physio-Control, Inc. |
| Report date | Feb 26, 2025 |
| Recall initiation date | Jan 21, 2025 |
| Quantity | 622 |
| Location | Redmond, WA, United States |
Official 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.
Why the product was recalled
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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