Covidien Nellcor Bedside SpO2 Patient Monitoring System Alarms May Not Sound
The Covidien Nellcor Bedside SpO2 Patient Monitoring System may not produce audible alarms, preventing caregivers from responding to low oxygen saturation or sensor disconnection. This can delay treatment and cause respiratory failure or arrhythmia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall. The hazard qualifies as a risk-of-harm product where injury has not yet been reported, fitting the Score 3 criterion. Potential consequences include treatment delays, respiratory failure, and cardiac arrhythmia; however, no actual injuries or hospitalizations are stated in the source material.
Plain-English summary
The Covidien Nellcor Bedside SpO2 Patient Monitoring System (REF PM100N and related models) is being recalled. The system is designed to monitor oxygen saturation levels and alert caregivers to critical changes in patient status, but affected units have a malfunction where alarms may not sound or may not be recognized by operators.
When alarms fail to sound, caregivers may not be alerted to low oxygen saturation levels or sensor disconnection, potentially delaying appropriate treatment. According to the source material, this defect can result in treatment delays, lack of response to low oxygen saturation, respiratory failure, and arrhythmia.
The recall affects approximately 264,790 units distributed worldwide, including throughout the United States. The affected product models include PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, and related variants. The operator's manual emphasizes not silencing or decreasing alarm volume for patient safety and recommends setting monitors to Homecare Mode when used outside of hospital or professional settings.
Persons using affected monitors should contact the manufacturer or refer to the official FDA recall notice (Z-2151-2025) for guidance on device replacement, repair, or remediation.
The recalled product
- Product
- Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
- Manufacturer
- Covidien
- Hazard
- alarm-failure
- respiratory-failure
- arrhythmia
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UI-DI/Bundle Code/IFU Part Number: PM100N/10884521196728/NELL-HOMECARE
- BNPULSOKSYMETR
- PM100N
- PM100NKIT
- PM100NKITCHDE
- PM100NKITCHFR
- PM100NKITDA
- PM100NKITDE-2
- PM100NKITES
- PM100NKITFI
- PM100NKITFR
- PM100NKIT-FR
- PM100NKITIT
- PM100NKIT-NL
- PM100NKITNO
- PM100NKITPT
- PM100NKITSV
- PM100NKITUK
- PM100N-10
- PM100N-2XMAXN
Distribution
Distributed nationwide across the United States.
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