Lower risk Medical device recall · FDA · Published January 21, 2025

Physio-Control LIFEPAK 15 V4 Sensors: Error Message Prevents SpCO/SpMet Monitoring

Physio-Control recalls LIFEPAK 15 V4 and Masimo Rainbow Sensors due to an error message blocking carboxyhemoglobin and methemoglobin saturation readings. Affected units include specific model numbers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1184-2025Medical device Physio-Control ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmPhysio-Control, Inc.11811 Willows Rd Ne · Redmond, WA 98052-2003

✎ GovInfoNow plain-language explainer

Physio-Control is recalling LIFEPAK 15 V4 monitors and Masimo Rainbow sensors because an error message prevents accurate carboxyhemoglobin and methemoglobin saturation readings. This could lead to incorrect patient monitoring during critical medical situations. Read more at govinfonow.com/recall/53054-physio-control-lifepak-15-v4-sensors-error-message-prevents-spco.

Source Summary by GovInfoNow · govinfonow.com/recall/53054-physio-control-lifepak-15-v4-sensors-error-message-prevents-spco · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1184-2025

Cite this page

“Physio-Control LIFEPAK 15 V4 Sensors: Error Message Prevents SpCO/SpMet Monitoring.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53054-physio-control-lifepak-15-v4-sensors-error-message-prevents-spco. Based on FDA recall #Z-1184-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1184-2025%22&limit=1).

Physio-Control, Inc. recalled LIFEPAK 15 V4/Masimo Rainbow Sensors due to an error message preventing use of carboxyhemoglobin and methemoglobin saturation sensors, according to the FDA on Jan. 21, 2025.

How to tell if you have it

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 hazard

The recall addresses an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system, according to the FDA.

Context

GovInfoNow's records show Physio-Control, Inc. has had 17 other recalls since Oct. 27, 2017. Other recent recalls include LIFEPAK 15 Defibrillators serviced without objective evidence of a Performance Inspection Procedure (April 13, 2026), Infant/Child Defibrillator Electrodes with delamination risk (Jan. 21, 2026), and LIFEPAK 15 Defibrillator units where required inspections were not performed (July 22, 2025). Other recent recalls of similar products include Spacelabs Healthcare Multi-parameter Command Module Model 91496 with inaccurate cardiac output readings (Feb. 27, 2026).

How to tell if you have this one

Check for the specific model numbers: 11996-000515 (adult adhesive), 11996-000519 (adult reusable), and 11996-000520 (pediatric reusable). Lot numbers include 23G79, 23HER, 23HPT, 23JBN, 23JTA, 23HNV, and 23JBP.

Brand
Physio-Control
Product
LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the sensor packaging or device label to confirm if it's affected.
Contact Manufacturer
Reach out to Physio-Control directly for guidance on whether your specific unit is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 27 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 36 days after the firm started it.

Jan 21, 2025Firm started the recall
Feb 19, 2025FDA classified it Class II
Feb 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53054-physio-control-lifepak-15-v4-sensors-error-message-prevents-spco">Physio-Control LIFEPAK 15 V4 Sensors: Error Message Prevents SpCO/SpMet Monitoring (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1184-2025 (January 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1184-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.