International safety notice

Based on the survey results of overseas manufacturers, the INVOS Adult N Sensor (P MSENS71-P-10), INVOS Adult N Sensor 20 (PMSENS71-P-20) and/or INVOS Pediatric N Sensor (PMSENS71-P-10)), when the INVOS 7100 monitor (PM7100) is connected to "CHECK SENSOR" or "REPLACE SENSOR" It has been discovered that there is a possibility of displaying an alarm message "Replacing the battery." Additionally, it has been determined that the incident was caused by a manufacturing defect in a specific connector part of the PMAC71RSC. As of December 2023, we have received 121 reports in Japan and overseas that are considered to be related to this event. We have not received any reports of health hazards related to the contents of the main recall. However, the alarm message "CHECK SENSOR" or "REPLACE SENSOR" rSO2 measurement cannot be carried out due to the occurrence of sage, or the obtained rSO2 measurement value is inaccurate. Adverse events may include delays in the surgical procedure due to the inability to perform rSO2 measurements and/or Due to the possibility that the O2 measurement value may be inaccurate, we have decided to carry out a voluntary recall.

Japan / PMDA Recalls · JPN · Jan 11, 2024