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.
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
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.
The error message prevents the device from displaying carboxyhemoglobin saturation (SpCO) and methemoglobin saturation (SpMet) readings. These measurements are critical for detecting certain toxic exposures or blood disorders that could affect patient safety during cardiac monitoring.
Healthcare providers using the LIFEPAK 15 V4 monitor with Masimo Rainbow sensors for cardiac care. Patients receiving monitoring in hospitals, clinics, or home settings are most at risk if the error message causes inaccurate readings.
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.
Identify the model number on the sensor packaging or device label to confirm if it's affected.
Reach out to Physio-Control directly for guidance on whether your specific unit is affected and next steps.
The recall is due to an error message that prevents the device from displaying carboxyhemoglobin and methemoglobin saturation readings, which are critical for certain patient conditions.
No, the recall does not require immediate discontinuation. Healthcare providers should check the model numbers and lot numbers to determine if their units are affected.
Contact Physio-Control directly to confirm if your specific model and lot numbers are affected and follow their instructions.
We’ve drafted a message you can send Physio-Control to request your refund or repair — edit it as you like.
Subject: Recall Z-1184-2025 — Physio-Control Physio-Control Hello, I own a Physio-Control that is covered by recall Z-1184-2025 from Physio-Control. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
