Recall Z-1184-2025 ยท MKJ Automated External Defibrillators (Non-Wearable)
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 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 s
| Date | Feb 19, 2025 (initiated Jan 21, 2025) |
| Status | Open, Classified |
| Reason | Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system. |
| 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 emai |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.