Z-1184-2025Class II

LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors...

Name: Z-1184-2025 LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors...
Creator: Physio-Control, Inc.
Published: 2025-01-21
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2025-01-21 / Open, Classified / root cause: design

FDA source

Physio-Control, Inc. began a recall of 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... on 2025-01-21. FDA classified it as Class II and gives the reason as "Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1184-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-21
Posted: 2025-02-19
Recalling firm: Physio Control, Inc.
Product: 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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Root cause tag: design
FDA root cause: Device Design
Action: On 1/21/2025, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day mail to customers to inform them that the LIFEPAK 15 V4 displays an error where "SpO2: Sensor does not support SpCO or SpMET". The error results in preventing users from utilizing LIFEPAK 15 V4 SpCO and SpMet functionalities when connected to specific lots of Masimo Rainbow Sensors. Customers are instructed to: 1. Immediately check your internal inventory to locate the product listed on the attached business reply form and remove them from their point of use. 2. Return the enclosed business reply form by email to [email protected] to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return and replacement of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. Please keep this communication close to the affected items until replacement. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. For questions or concerns - contact Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at [email protected].
Quantity in commerce: 622
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.
Product codes and lots: Catalog Number: 11996-000515 UDI-DI/GTIN code: 00843997010863 Lot Number: 23G79 Catalog Number: 11996-000519 UDI-DI/GTIN code: 00843997015608 Lot Numbers: 23HER 23HPT 23JBN 23JTA Catalog Number: 11996-000520 UDI-DI/GTIN code: 00843997015615 Lot Numbers: 23HNV 23JBP

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1184-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-26	2025-02-19

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)