Recall Z-2151-2025— Covidien
Class II · Ongoing
Class II FDA medical device recall by Covidien, initiated 2025-06-23. It names 2 FDA 510(k) clearances: K142865, K120773. Product: Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN. Reason: Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting.
- Recalling firm
- Covidien
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-23
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
2 on FDA's record- K142865 — Nellcor Bedside SpO2 Patient Monitoring System
- K120773 — NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Reason for recall
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Data sourced from openFDA. This site is unofficial and independent of the FDA.