Physio-Control, Inc.: 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 Reusabl

Hazard

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

Details from the source

Reason for recall: Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. 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. Quantity: 622 Lot/code info: 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

UPC codes

00843997010863, 00843997015608, 00843997015615

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.